Multi-center, Prospective, Open Label, Single Arm Post-market Study of BD NRFit™ Spinal Needles, NRFit™ Spinal Introducer Needles, and NRFit™ Syringes on Participants Who Are Receiving Neuraxial Procedure.
Conditions: Anesthesia, Analgesia
Sponsor: Becton, Dickinson and Company

Protocol Number: MDS-21NRFit001 
 
CONFIDENTIAL 
Version: 2.0 
Date: 10JAN2023 
Page 1 of 56 
Title Page 
Protocol Title:  Multi-center, prospective, open label, single arm post-market study of BD 
NRFit™ Spinal Needles, NRFit™ Spinal Introducer Needles, and NRFit™ 
Syringes on participants who are receiving neuraxial procedure. 
 
 
Protocol Number: MDS-21NRFit001 
 
Version Number: 2.0 
 
Study Device: BD Spinal NRFit™ Needles 
BD Spinal Introducer NRFit™ Needle 
BD Spinal NRFit™ Needle Sets 
BD Syringes NRFit™ 
 
Study Type: Post-market Clinical Follow-up Study 
 
Short Title: Prospective Clinical Evaluation of BD NRFit™ devices and accessories 
 
Sponsor Name: Becton, Dickinson and Company  
 
Legal Registered Address: 1 Becton Drive, 
Franklin Lakes, New Jersey 07417 
USA 
 
European Representative:  BDI Benelux 
Hagelberg 2,2250 Olen, Belgium 
Sponsor Contact:  
Gloria Viti 
Clinical Project Manager 
Clinical Research EMEA 
Via Enrico Cialdini, 16 
20161 Milano, Italy 
T: +39 3452237718 
gloria.viti@bd.com 
 
Regulatory Agency Identifier Number(s): N/A 
 
Version History 
Version Number 
Date 
Type 
2.0 
10-Jan-2023 
Amendment 
1.0 
11-Nov-2022 
Initial release 

Protocol Number: MDS-21NRFit001 
 
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Sponsor Protocol Approval 
Signature below indicates approval of the protocol as written. 
Individual or 
function 
Name 
Signature 
Date 
Medical Affairs 
Team Representative 
Edward A. Maratea, Jr 
This document is signed 
electronically in the eTMF 
system 
Study Statistician 
Shuangshuang Fu 
This document is signed 
electronically in the eTMF 
system 
Regulatory Affairs 
John Roberts 
This document is signed 
electronically in the eTMF 
system 
Project Manager 
Gloria Viti 
This document is signed 
electronically in the eTMF 
system 
 
 
 

Protocol Number: MDS-21NRFit001 
 
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Protocol Signature Page 
Investigator Responsibilities 
 
1. Prior to participation in this study, the Investigator or Institution must sign the Clinical 
Study Agreement (CSA) and obtain written approval from the appropriate Institutional 
Review Board (IRB)/Ethics Committee (EC). 
2. The Investigator must receive BD-sponsored training prior to site activation. The 
Investigator is responsible for ensuring that all Sub-Investigators and clinical staff are 
adequately trained prior to performing any data collection or study-related procedures.   
3. The Principal Investigator shall ensure that the study is conducted in accordance with the 
study protocol, any modifications as requested by the IRB/EC, the signed CSA, the 
ethical principles of the Declaration of Helsinki, Good Clinical Practice (ICH E6) / ISO 
14155), and applicable national/regional regulations and laws. 
4. If applicable, ensure that written informed consent is obtained from each participant prior 
to the conduct of any study procedure, using the current IRB/EC approved Informed 
Consent Form. 
 
 
I have read and understand the contents of this study protocol. I agree to follow and abide by the 
requirements set forth in this document. I agree to conduct the trial in accordance with 
the study protocol, the signed Clinical Study Agreement, and Good Clinical Practice (GCP) as 
well as Ethical principles that have their origin in the Declaration of Helsinki, EU MDR (Council 
Regulation 2017/745 of 5 April 2017), applicable FDA, and ISO regulations (e.g., 21 CFR 
Parts 812, 50, 54, 56; ISO 14155:2020). I agree to participate in BD-Sponsored training prior to 
performing any data collection or study-related procedures. 
 
 
Agreed to by (Investigator):  
  
_______________________________________________  
Printed Name – Investigator   
  
_______________________________________________  
Signature – Investigator  
 
_______________________________________________  
 Site Number 
 
_______________________________________________  
Date  
 

Protocol Number: MDS-21NRFit001 
 
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Date: 10JAN2023 
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Protocol Amendment Summary of Changes 
Amendment 2.0 (10Jan2023) 
This amendment is considered to be nonsubstantial based on the criteria set forth in Article 10(a) 
of Directive 2001/20/EC of the European Parliament and the Council of the European Union 
because it neither significantly impacts the safety or physical/mental integrity of participants nor 
the scientific value of the study. 
 
Overall Rationale for the Amendment:  
 
The rationale for the amendment is to provide clarifications described in the summary of changes 
table in order to obtain consistency through the entire document.  
 
Summary of Changes Table 
 
Location of 
Original Text 
Original Text 
New Text 
Rationale for Change 
Header/Title 
Page 
Version Number: 1.0 
Version Number: 2.0 
Version Control 
Header/Title 
Page 
Date: 11Nov22 
Date: 10Jan23 
Version Control 
Header/Title 
Page 
Legal Registered Address:  
1 Becton Drive,  
Franklin Lakes, New Jersey 
07417 
US 
Legal Registered Address:  
1 Becton Drive,  
Franklin Lakes, New Jersey 
07417 
USA 
Clarification: typo error. 
Header/Title 
Page 
European Representative: 
Angiomed GmbH & Co 
Medizintechnik KG 
Wachhausstr,6 
76227 Karlsruhe, Germany 
European Representative: 
BDI Benelux 
Hagelberg 2,2250 Olen, 
Belgium 
Clarification/modification: 
European Representative 
name change. 
Section 4.1: 
Overall Design 
Participants will be followed from 
the time of enrollment for up to 
10 days (± 3 days) post spinal 
procedure to assess for any 
adverse events/complications. 
Participants will be followed 
from the time of spinal 
procedure for up to 10 days (± 3 
days) post spinal procedure to 
assess for any adverse 
events/complications. 
Clarification/modification: 
spinal procedure in 
replacement of enrollment 
in order to be consistent 
with the schedule of 
activities.  
Section 1.1 
Synopsis: 
intervention(s)
/procedure(s) 
 
Section 5.7: 
Participant 
duration 
The duration of study 
participation for an individual 
subject is expected to be 10 days, 
± 3 days, (from procedure through 
last visit). 
The duration of study 
participation for an individual 
subject is expected to be 11 
days, ± 3 days, (from procedure 
through last visit). 
Clarification/modification: 
11 days instead of 10 days 
in order to include in the 
participant study duration 
the day of the spinal 
procedure.  

Protocol Number: MDS-21NRFit001 
 
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Location of 
Original Text 
Original Text 
New Text 
Rationale for Change 
Section 1.1 
Synopsis: 
intervention(s)
/procedure(s) 
 
Section 7.2: 
Medical 
History/Demo
graphy/Baselin
e assessments 
Sex assigned at birth 
Sex assigned at birth and ethnic 
origin 
Added “ethnic origin” as 
data that will be 
documented. 
Section 7.3.1: 
Spinal 
procedure data 
• Spinal NRFit™ Needle type, 
gauge, length, catalog number, 
and lot number 
• Spinal NRFit™ Needle type, 
gauge, length, catalog number, 
expire date and lot number 
Added “expire date” as data 
that will be documented. 
 
• Spinal NRFit™ Introducer, 
gauge, length, catalog number, 
and lot number (if used) 
• Spinal NRFit™ Introducer, 
gauge, length, catalog number, 
expire date and lot number (if 
used) 
 
 
• Syringes NRFit™ type, size, 
catalog number, and lot number 
• Syringes NRFit™ type, size, 
catalog number, expire date and 
lot number 
 
 
• Spinal NRFit™ set type, gauge, 
length, catalog number, and lot 
number 
• Spinal NRFit™ set type, 
gauge, length, catalog number, 
expire date and lot number 
 
Section 9.4: 
Reporting of 
Events 
All SAEs, SADEs, and/or 
UADEs/USADEs must be 
reported to the Sponsor via 
electronic CRF without 
unjustified delay and within three 
(3) working days of the 
site/investigator becoming aware 
of the event.   
All SAEs, SADEs, and/or 
UADEs/USADEs must be 
reported to the Sponsor via 
electronic CRF without 
unjustified delay and within 
three (3) calendar days of the 
site/investigator becoming 
aware of the event.   
Clarification/modification: 
three working days 
replaced with three 
calendar days in order to be 
in compliance with MDGC 
2020-10/1 Rev.1 
guidelines. 
Section 9.6: 
Device 
Deficiencies 
All mechanical failures, 
malfunctions, missing 
components, and defects of the 
study devices will be recorded on 
the appropriate Case Report Form 
and will be promptly reported to 
the Sponsor. 
All device deficiencies will be 
recorded on the appropriate 
Case Report Form and will be 
promptly reported to the 
Sponsor. 
Clarification/modification: 
“all mechanical failures, 
malfunctions, missing 
components, and defects of 
the study devices” sentence 
has been replaced with “all 
device deficiencies” in 
order to not duplicate the 
same information and to 
express clearly that all 
device deficiencies have to 
be recorded in the case 
report form. 

Protocol Number: MDS-21NRFit001 
 
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Table of Contents 
1 
Protocol Summary ................................................................................................................ 10 
1.1 
Synopsis ......................................................................................................................... 10 
1.2 
Schema ........................................................................................................................... 16 
1.3 
Schedule of Activities .................................................................................................... 17 
2 
Introduction ........................................................................................................................... 18 
2.1 
Background .................................................................................................................... 19 
2.2 
Rationale......................................................................................................................... 20 
2.3 
Risk/Benefit Assessment ................................................................................................ 20 
2.3.1 
Risk Assessment ..................................................................................................... 20 
2.3.2 
Benefit Assessment ................................................................................................. 23 
2.3.3 
Overall Benefit: Risk Conclusion ........................................................................... 23 
3 
Objectives and Endpoints ..................................................................................................... 23 
3.1 
Acceptance Criteria ........................................................................................................ 24 
4 
Study Design ......................................................................................................................... 25 
4.1 
Overall Design................................................................................................................ 25 
4.2 
Scientific Rationale for Study Design ............................................................................ 25 
4.2.1 
Participant Input into Design .................................................................................. 25 
4.3 
End of Study Definition ................................................................................................. 25 
5 
Study Population ................................................................................................................... 26 
5.1 
Inclusion Criteria ............................................................................................................ 26 
5.2 
Exclusion Criteria ........................................................................................................... 26 
5.3 
Lifestyle Considerations ................................................................................................. 26 
5.4 
Screen Failures ............................................................................................................... 26 
5.5 
Vulnerable Population .................................................................................................... 27 
5.6 
Point of Enrolment ......................................................................................................... 27 
5.7 
Participation duration ..................................................................................................... 27 
6 
Study Interventions ............................................................................................................... 27 
6.1 
Investigational/Test Device ............................................................................................ 27 
6.2 
Control Device/Standard of Care ................................................................................... 29 
6.3 
Ancillary Devices/Products ............................................................................................ 29 
6.4 
Device Labeling ............................................................................................................. 29 
6.5 
Treatment Allocation and Measures to Minimize Bias .................................................. 29 
7 
Study Procedures and Assessments ...................................................................................... 30 

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7.1 
Screening and Enrollment .............................................................................................. 30 
7.2 
Medical History / Demography / Baseline Assessments ............................................... 30 
7.3 
Spinal procedure ............................................................................................................. 31 
7.3.1 
Spinal procedure data .............................................................................................. 31 
7.3.2 
Ease of Use Procedure Survey ................................................................................ 32 
7.4 
Follow-Up ...................................................................................................................... 32 
7.4.1 
Follow-Up data ....................................................................................................... 32 
8 
Participant Discontinuation/Withdrawal ............................................................................... 33 
8.1 
Discontinuation/Withdrawal .......................................................................................... 33 
8.2 
Lost to Follow-Up .......................................................................................................... 33 
9 
Adverse Events and Device Deficiencies ............................................................................. 34 
9.1 
Definitions of Events ...................................................................................................... 34 
9.1.1 
Adverse Events (AEs) ............................................................................................. 34 
9.1.2 
Serious Adverse Events (SAEs).............................................................................. 34 
9.1.3 
Adverse Device Effect (ADE) / Serious Adverse Device Effect (SADE) .............. 35 
9.1.4 
Unanticipated (Serious) Adverse Device Effect (UADE/USADE) ........................ 35 
9.2 
Severity of Adverse Events ............................................................................................ 35 
9.3 
Relationship of Adverse Event to Device(s)/Procedure ................................................. 35 
9.4 
Reporting of Events ........................................................................................................ 37 
9.5 
Safety Committees ......................................................................................................... 38 
9.6 
Device Deficiencies........................................................................................................ 38 
9.7 
Serious Health Threat ..................................................................................................... 38 
10 Statistical Methods ................................................................................................................ 39 
10.1 Overview of Study Design ............................................................................................. 39 
10.2 Sample Size Considerations ........................................................................................... 39 
10.3 Analysis Population........................................................................................................ 39 
10.4 General Considerations .................................................................................................. 40 
10.5 Primary Endpoint(s) ....................................................................................................... 40 
10.5.1 Primary Performance Endpoints ............................................................................. 40 
10.5.2 Primary Safety Endpoints ....................................................................................... 40 
10.6 Other Analyses ............................................................................................................... 41 
11 Data Collection and Record Maintenance ............................................................................ 41 
11.1 Case Report Forms ......................................................................................................... 41 
11.2 Source Documentation ................................................................................................... 41 

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11.3 Data Management .......................................................................................................... 41 
11.4 Record Retention ............................................................................................................ 42 
12 Quality Control and Assurance ............................................................................................. 42 
12.1 Control of Study Products .............................................................................................. 42 
12.2 Monitoring ...................................................................................................................... 42 
12.3 Audits and Inspections ................................................................................................... 43 
12.4 Protocol Deviations ........................................................................................................ 43 
13 Administrative Requirements ............................................................................................... 44 
13.1 Investigator and Site Selection ....................................................................................... 44 
13.2 Training .......................................................................................................................... 44 
13.3 Required Documents ...................................................................................................... 44 
13.4 Insurance ........................................................................................................................ 45 
13.5 Publication Policy .......................................................................................................... 45 
13.6 Study Registration .......................................................................................................... 45 
13.7 Termination of Study ..................................................................................................... 45 
14 Ethical and Regulatory Considerations ................................................................................. 46 
14.1 IRB/EC Approval ........................................................................................................... 46 
14.2 Informed Consent and Confidentiality ........................................................................... 46 
14.2.1 Confidentiality ........................................................................................................ 47 
14.3 Regulatory Status ........................................................................................................... 47 
14.4 Statement of Compliance ............................................................................................... 47 
15 References ............................................................................................................................. 49 
16 Appendices ............................................................................................................................ 53 
16.1 Study devices.................................................................................................................. 53 
16.2 ASA physical status (PS) classification - Current Definitions and ASA-Approved 
Examples [54] ........................................................................................................................... 55 
 
 

Protocol Number: MDS-21NRFit001 
 
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Abbreviations 
ADE 
Adverse Device Effect 
AE 
Adverse event 
ASADE 
Anticipated Serious Adverse Device Effect 
BD 
Becton Dickinson and Company 
BMI 
Body Mass Index 
CFR 
Code of Federal Regulations 
CI 
Confidence Interval 
CIP 
Clinical Investigation Plan 
CRF 
Case Report/Record Form 
CRO 
Contract Research Organization 
CSA 
Clinical Study Agreement 
CSF 
Cerebrospinal Fluid 
CV 
Curriculum Vitae 
DMP 
Data Management Plan 
EDC 
Electronic Data Capture 
EMEA 
Europe, the Middle East and Africa 
EU 
European Union 
FDA 
Food and Drug Administration 
FDAAA 
FDA Amendments Act of 2007 
GCP 
Good Clinical Practice 
GDPR 
General Data Protection Regulation 
HIPAA  
Health Insurance Portability and Accountability Act 
ICH 
International Conference on Harmonization 
ICF 
Informed Consent Form 
IFU 
Instructions for Use 
IRB/EC 
Institutional or Independent Review Board/Ethics Committee 
ISO 
International Organization for Standardization 
LAR 
Legal Authorized Representative 
MDCG 
Medical Device Coordination Group 
PDPH 
Post-Dural Puncture Headache 
PI 
Principal Investigator 
RMV 
Routine Monitoring Visit 
SAE 
Serious Adverse Event 
SADE 
Serious Adverse Device Effect 
SAP 
Statistical Analysis Plan 
SD 
Standard Deviation 
SoA 
Schedule of Activities 
SOP 
Standard Operating Procedure 
™ 
Trademark 
TMF 
Trial Master File 
USADE 
Unanticipated Serious Adverse Device Effect 
WHO 
World Health Organization 
 
 
 

Protocol Number: MDS-21NRFit001 
 
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1 PROTOCOL SUMMARY 
1.1 
Synopsis 
Protocol Title 
Multi-center, prospective, open label, single arm post-market study of BD 
NRFit™ Spinal Needles, NRFit™ Spinal Introducer Needles, and NRFit™ 
Syringes on participants who are receiving neuraxial procedure. 
Short Title 
Prospective Clinical Evaluation of BD NRFit™ devices and accessories 
Rationale 
This study is designed to assess the safety and performance of the BD Spinal 
NRFit™ Needles, BD Spinal NRFit™ Needle Sets, BD Spinal Introducer 
NRFit™ Needles, BD Syringes NRFit™ devices, mainly, but not limited to 
the purpose of providing clinical data required under European Union (EU) 
regulation 2017/745. 
Objectives and Endpoints 
Objectives 
Endpoints 
Primary Performance Objectives 
• To assess the performance of the 
BD Spinal NRFit™ needles and 
BD NRFit™ introducers used in 
spinal anesthesia procedures. 
Primary Performance Endpoints 
• Percentage of participants with 
successful placement of the BD 
Spinal NRFit™ needle in the 
subarachnoid location defined as the 
spontaneous appearance of 
cerebrospinal fluid (CSF) emerging 
from the spinal needle hub. 
• Percentage of participants with 
successful placement of the BD 
Spinal NRFit™ needle in the 
subarachnoid location defined as the 
spontaneous appearance of 
cerebrospinal fluid (CSF) emerging 
from the spinal needle hub when an 
BD NRFit™ introducer is used. 
• To assess the performance of BD 
NRFit™ Syringes when used in 
spinal anesthesia procedures. 
• Percentage of participants with 
successful aspiration and injection of 
anesthetic through a BD NRFit™ 
Syringe. 
• Percentage of participants with BD 
NRFit™ Syringes that do not leak at 
the connection point during 
medication administration. 

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Primary Safety Objectives  
Primary Safety Endpoints 
 
• To assess the incidence of post 
dural puncture headache (PDPH). 
• Percentage of participants with a 
diagnosis of PDPH (defined as 
headache that worsens when 
standing/upright position and 
relieves when laying supine) for a 
period of up to 10 (± 3 days) * days 
following the procedure. 
 
• To assess the incidence of any 
BD NRFit™ spinal needle and 
BD NRFit™ introducer and BD 
NRFit™ syringe and procedure-
related adverse events (other than 
PDPH). 
• Incidence of any device/procedure 
related adverse events. 
*The time window of ± 3 days must be used 
when the 10-day post-procedure occurs during 
the weekends or holidays. 
Design and Overview 
This is a multi-center, prospective, open label, single arm post-market study 
that will enroll approximately 180 participants in order to have a minimum of 
150 treated participants who will receive a spinal anesthesia procedure as part 
of their routine medical care. Participants will be followed from the time of 
enrollment for up to 10 days (± 3 days) post spinal anesthesia procedure for 
evidence of adverse events including PDPH. This can be done via phone if 
the participant is discharged from the hospital. The site staff must take 
advantage of the time window of ± 3 days only when the 10-day post-
procedure occurs during the weekends or holidays. Any adverse event or 
complication must be diagnosed and confirmed by a study physician. 
A minimum of 50 participants for each of the two needle tip types (Quincke 
and Whitacre tip) will be enrolled in the study. 
The spinal anesthesia procedure may be performed by clinicians trained in 
the use of Spinal Needles. Specialized training is required for operation of the 
Spinal Needle. 

Protocol Number: MDS-21NRFit001 
 
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Study Devices 
The full range of CE-marked devices marketed in the EU will be available 
for use in this study. These devices include: 
• BD Spinal NRFit™ Needles: BD Quincke Spinal NRFit™ Needle and 
BD Whitacre Spinal NRFit™ Needle 
• BD Spinal Introducer NRFit™ Needle 
• BD Spinal NRFit™ Needle Sets: BD Quincke Spinal NRFit™ Needle Set 
and BD Whitacre Spinal NRFit™ Needle Set 
• BD Syringes NRFit™: BD Syringes NRFit™ Lok and BD Syringes 
NRFit™ Slip 
• Ancillary devices: BD Blunt Fill NRFit™ needle and BD Blunt Filter 
NRFit™ needle 
The BD Quincke Spinal NRFit™ Needle and BD Whitacre Spinal NRFit™ 
Needle, hereinafter referred to as the BD Spinal NRFit™ Needles, are 
intended to gain entry into or puncture the spinal cavity permitting injection 
(including anesthesia)/withdrawal of fluids for purposes of diagnostic lumbar 
puncture and myelography procedures.  
The BD Spinal Introducer NRFit™ Needle is intended for placement or 
introduction of spinal needles. 
BD Quincke Spinal NRFit™ Needle Set and BD Whitacre Spinal NRFit™ 
Needle Set consist of either a BD Quincke Spinal NRFit™ Needle or a BD 
Whitacre Spinal NRFit™ Needle and a BD Spinal Introducer NRFit™ 
Needle, hereinafter referred to as the BD Spinal NRFit™ Needle Sets.  
BD Syringes NRFit™ Lok and BD Syringes NRFit™ Slip, hereinafter 
referred to as the BD Syringes NRFit™, are intended for neuraxial use by 
healthcare professionals for aspiration/injection of fluids. 
The choice of the specific BD Spinal NRFit™ Needle, gauge, length, tip, 
type, and size of a BD Syringes NRFit as well as the option of using a BD 
Spinal NRFit™ Needle set and BD Spinal Introducer NRFit™ Needle, 
required for an individual participant is left to the discretion of the clinician. 
BD Spinal Introducer NRFit™ Needle sizes paired to selected BD Spinal 
NRFit™ Needles may be used. 
The BD Blunt Fill NRFit™ needle is used for aspiration of fluids from vials 
and ampoules. The BD Blunt Filter NRFit™ needle is used for aspiration and 
filtration of fluids from vials and ampoules. The BD Blunt Fill NRFit™ and 
BD Blunt Filter NRFit™ Needles are not for skin injections. 
All devices used in this study will be used in a manner consistent with their 
labelled indications. 

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Participants 
Approximately 180 participants will be enrolled in order to have a minimum 
of 150 treated participants. A minimum of 50 participants for each of the two 
needle tip types (BD Quincke Spinal NRFit™ Needle and BD Whitacre 
Spinal NRFit™ Needle) will be treated in the study.  
In order to be eligible to participate in this study, an individual must meet all 
of the following criteria: 
1. Any patient, regardless of age or gender, for which the investigator 
has decided that a neuraxial procedure must be performed utilizing 
BD NRFit™ Spinal Needles, NRFit™ Spinal Introducer Needles, 
and NRFit™ Syringes as part of their routine medical care. 
2. Expected to be available for observation through the study period (10 
days, ± 3 days*, post procedure). 
3. Able and willing to provide signed and dated informed consent or 
legal authorized representative (LAR) authorized to give consent on 
behalf of the participant (Note: Consent of guardian or parent may be 
required for participants under the age of 18 years; participant assent 
may be required as well). 
*The time window of ± 3 days must be used when the 10-day post-procedure occurs during the 
weekends or holidays. 
Participants are excluded from the study if any of the following criteria 
apply: 
1. Coagulopathy or bleeding disorder, where it is in the opinion of the 
investigator makes regional anesthetic of increased risk.   
2. Subjects with a history of neurological impairment of the trunk or 
lower extremities. 
3. Infection at the site of needle insertion. 
4. Previous spine surgery at the level involved in the study procedure. 

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Intervention(s)/Procedure(s) After general screening against inclusion/exclusion criteria, potential 
participants will be provided with detailed information about the study. If the 
potential participant, or legal authorized representative (LAR) authorized to 
give consent on behalf of the participant, or parent/guardian and potential 
participant in the case of those under 18 years of age, provides written 
informed consent/assent, respectively, he/she will be enrolled in the study.  
Participant baseline and demographic information will be documented 
including, but not limited to: age, sex assigned at birth, ethnic origin, reason 
for surgery/intervention, limited medical history, and reason for spinal 
anesthesia procedure. 
At the time of the spinal anesthesia procedure, information about the study 
devices and insertion procedure will be documented including, but not 
limited to: date and time of insertion, NRFit spinal needle, tip, gauge, and 
length, introducer NRFit™ gauge and length (if used), syringe NRFit™ type 
and size, dose medication preparation procedure (type of ancillary device 
used), participant position, use of local anesthesia, number of spinal needles, 
lumbar interspace, medications/agents injected. Additionally, to assess 
overall ease of spinal procedure, the clinician performing the procedure will 
complete a brief survey describing their experience with the procedure. 
The procedure will be performed using the devices and specific methods 
selected by the investigator.  Details of the procedure will be documented to 
ensure study endpoints are documented in the appropriate case report form. 
Device deficiencies/failures will be also collected.   
The participants will be accurately monitored as required for their routine 
medical care and according to site policy.  Complications or adverse events 
(e.g., PDPH) will be monitored for 10 days (± 3 days) after the procedure.  If 
the participant is discharged from the hospital prior to day-10 (± 3 days) post-
procedure, follow-up may be performed in a variety of ways including by 
telephone. The site staff must take advantage of the time window of ± 3 days 
only when the 10-day post-procedure occurs during the weekends or 
holidays. However, any adverse event or complication must be diagnosed 
and confirmed by a study physician.   
It is expected to take approximately 47 weeks to complete participant 
enrollment.  The total duration of the investigation is expected to be 
approximately 49-51 weeks from the first participant enrolled up to last 
participant having last visit. 
The duration of study participation for an individual subject is expected to be 
11 days, ± 3 days, (from procedure through last visit). 
Investigational Sites 
Up to 10 sites within Europe will participate in this study. No more than 25% 
of participants may be enrolled at any one site. 

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Data Monitoring 
Committee 
A Data Monitoring Committee will not be used in this study. 
Regulatory Status 
The BD Spinal NRFit™ Needles, BD Spinal Introducer NRFit™ Needle, BD 
Spinal NRFit™ Needle Sets, BD Syringes NRFit™, BD Blunt Fill NRFit™ 
needle and BD Blunt Filter NRFit™ needle are currently CE marked and 
marketed in the EU. 
 
 
 

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1.2 
Schema 
 
 
Potential participant is identified and screened against eligibility criteria. 
Refer to sections 5.1, 5.2 and 7.1 for more details. 
Participant consent or assent (if under the age of 18 years) is provided. 
Refer to section 14.2 for more details. 
Medical history, demographic and baseline information is collected. 
Refer to section 7.2 for more details. 
Participant receives spinal procedure as part of his/her routine medical care. The study devices 
used are left to the participant’s physician investigator. 
Refer to section 7.3 for more details. 
Participants will be followed from the time of enrollment for up to 10 days (± 3 days) post spinal 
procedure for evidence of adverse events including post dural puncture headache. If the participant 
is discharged from the hospital prior to day-10 (± 3 days) post-procedure, follow-up may be 
performed by telephone. The time window of ± 3 days must be used when the 10-day post-
procedure occurs during the weekends or holidays. 
Refer to section 7.4 for more details. 

Protocol Number: MDS-21NRFit001 
 
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1.3 
Schedule of Activities 
Procedure 
Baseline 
 
Spinal Procedure 
 
Follow-Up Visit2 
10 days (± 3 days) post spinal 
procedure 
Informed consent process, incl. Informed consent 
signature date 
X 
 
 
Inclusion and exclusion criteria 
X 
 
 
Baseline assessment and Demography  
X 
 
 
Limited Medical history 
X 
 
 
Spinal procedure intervention 
 
X 
 
Ease of use procedure survey 
 
X 
 
Adverse Event monitoring and assessment1 
 
=============================→ 
Serious Adverse Event monitoring and assessment 
 
=============================→ 
Device deficiencies monitoring and assessment 
 
=============================→ 
1 Participants will be monitored as required for their routine medical care and according to the hospital policy. Any adverse event or complication must be 
diagnosed and assessed by a study clinician. 
2 If the participant has been discharged from the hospital prior to day-10 (± 3 days) post-procedure, follow-up may be performed in a variety of ways including 
by telephone. The time window of ± 3 days must be used when the 10-day post-procedure occurs during the weekends or holidays. However, any adverse event 
or complication must be diagnosed and assessed by a study clinician. 
 

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2 INTRODUCTION 
Becton, Dickinson & Company manufactures a variety of devices used in neuraxial procedures, 
from medication preparation to delivery. These devices are used in medical procedures utilizing 
well-established methods. 
Neuraxial anesthesia is the administration of medication into the subarachnoid or epidural space 
to produce anesthesia and analgesia. It can lead to the complete absence of sensory and/or motor 
function at or below the site of injection. Depending on the dose and concentration of the 
anesthetic used, neuraxial anesthesia doesn’t always result in a complete absence of motor 
function [1]. 
Neuraxial anesthesia is performed by placing a needle between vertebrae and injecting 
medication into the epidural space (for epidural anesthesia) or the subarachnoid space (for spinal 
anesthesia) [2]. 
Spinal anesthesia is a type of neuraxial anesthesia; local anesthetic (LA) is injected into 
cerebrospinal fluid (CSF) in the lumbar spine to anesthetize nerves that exit the spinal cord. 
Spinal anesthesia is most commonly used for anesthesia and/or analgesia for a variety of lower 
extremity, lower abdominal, pelvic, and perineal procedures. Spinal anesthesia is also 
occasionally used for spine surgery [3].
Figure 1 Spinal anesthesia [4] 
The BD Quincke Spinal NRFit™ Needle and BD Whitacre Spinal NRFit™ Needle, hereinafter 
referred to as the BD Spinal NRFit™ Needles, are intended to gain entry into or puncture the 
spinal cavity permitting injection (including anesthesia) / withdrawal of fluids for purposes of 
diagnostic lumbar puncture and myelography procedures. 
The BD Spinal Introducer NRFit™ Needle is intended for placement or introduction of spinal 
needles. 
The BD Quincke Spinal NRFit™ Needle Set and BD Whitacre Spinal NRFit™ Needle Set 
consist of either a BD Quincke Spinal NRFit™ Needle or a BD Whitacre Spinal NRFit™ Needle 

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and a BD Spinal Introducer NRFit™ Needle, hereinafter referred to as the BD Spinal NRFit™ 
Needle Sets. The indications for use remain the same of those for the BD Spinal NRFit™ 
Needles and the BD Spinal Introducer NRFit™ Needle. 
The BD Spinal NRFit™ Needles, BD Spinal NRFit™ Needle Sets and BD Spinal Introducer 
NRFit™ Needle were launched in 2020 and they are currently marketed in the European Union 
(EU) and in other countries around the world. The BD Spinal NRFit™ Needles and BD Spinal 
NRFit™ Needle Sets are classified as class III medical devices and BD Spinal Introducer 
NRFit™ Needle is classified as a class IIa medical device. 
The BD Syringe NRFit™ Lok and BD Syringe NRFit™ Slip, hereinafter referred to as the BD 
Syringes NRFit™, are syringes with ISO 80369-6 (NRFit™) compliant lock or slip connectors. 
The BD Syringes NRFit™ devices are class IIa medical devices, as defined in the MDR (EU) 
2017/745. The BD Syringes NRFit™ devices are intended for neuraxial use by healthcare 
professionals for aspiration/injection of fluids. These devices are currently sold in the European 
Union (EU) and other countries. 
The ancillary devices as the BD Blunt Fill NRFit™ Needles and the BD Blunt Filter NRFit™ 
Needles are classified as class I medical devices and they are used for aspiration of fluids and for 
aspiration and filtration of fluids from vials and ampoules, respectively. 
2.1 
Background 
A 2009 study of obstetric anesthesia practice found four deaths due to administration of 
tranexamic acid into the neuraxis [5]. Errors of this type are referred to as misconnections or 
wrong-route drug delivery. This 2009 study is just one example of death or serious harm that 
can result from wrong-route drug delivery. Misconnections are often the result of accidental 
administration of substances, that are safe to deliver intravascularly, via the neuraxial route.  
Authors across disciplines [6], [7] have concluded that the mortality and morbidity associated 
with such errors is secondary to the universal adoption of Luer lock equipment [8]. 
Furthermore, sentinel interest groups in the US and the EU have issued warnings about the 
risk of universal Luer connectors, that allow these misconnections [9]. Therefore, 
implementation of devices with non-Luer connectors could improve patient safety and 
decrease the risk of misconnections [6]. 
The goal of the ISO 80369 standard for Small Bore Connectors is to reduce the risk of 
misconnections between medical devices or between accessories for different applications. 
ISO 80369-6:2016 specifies requirements for small bore connectors intended to be used for 
connections in neuraxial applications. Neuraxial applications involve the use of medical 
devices intended to administer medications to neuraxial sites, wound infiltration anesthesia 
delivery, other regional anesthesia procedures and monitoring or removing cerebrospinal 
fluid for therapeutic or diagnostic purposes. The neuraxial ISO 80369-6 devices have been 
designated as NRFit. They are visually identifiable by an NRFit label and yellow device 
components, both of which denote that the device is only for neuraxial use. 
BD manufactured ISO 80369-6 compliant devices from medication preparation to delivery, 
such as the spinal NRFit™ needles, the spinal introducer NRFit™ needles, the spinal 
NRFit™ needle sets, the syringes NRFit™, the blunt fill and blunt filter NRFit™ needles. 

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2.2 
Rationale 
This study is designed to assess the safety and performance of the BD Spinal NRFit™ 
Needles, BD Spinal NRFit™ Needle Sets, BD Spinal Introducer NRFit™ Needles, BD 
Syringes NRFit™ devices, mainly, but not limited to the purpose of providing clinical data 
required under European Union (EU) regulation 2017/745.  
2.3 
Risk/Benefit Assessment 
Since only participants requiring use of one of the study devices as part of their standard 
medical care, there are no anticipated risks and benefits associated with participation in the 
study other than those associated with device usage and with the neuraxial procedure. More 
detailed information about the known and expected benefits and risks and reasonably 
expected adverse events of BD Spinal NRFit™ Needles, the BD Spinal Introducer NRFit™ 
Needles, BD Spinal NRFit™ Needle Sets, and the BD Syringes NRFit™ devices may be 
found in their respective Instructions for Use (IFUs). 
2.3.1 Risk Assessment 
Potential Risk of Clinical 
Significance 
Summary of Data/Rationale 
for Risk 
Mitigation Strategy 
Study Intervention (s): BD Spinal NRFit™ Needles and BD Spinal NRFit™ Sets 
Complications vary based upon 
anatomic site and clinician 
experience and may include: 
• localized/systemic infection, 
• exposure to bodily fluids 
and/or bloodborne pathogens, 
• subarachnoid/subdural/epidural 
(spinal) hematoma,  
• herniation,  
• low back pain,  
• paresthesia,  
• accidental puncture of the 
dura, 
• post dural puncture headache,  
• total subarachnoid block, 
• seizures,  
• pneumocephalus,  
• nerve injury,  
• cerebral ischemia or 
hemorrhage,  
• bladder dysfunction from 
prolonged blockade,  
• cauda equine syndrome,  
• transient neurologic symptoms,  
• adhesive arachnoiditis, 
A benefit-risk assessment for 
the overall medical device is 
documented in the Risk 
Management Report.  
All risks and combinations of 
risks were reviewed, and it has 
been determined that all are 
within acceptable limits. The 
benefits of the device outweigh 
each risk individually as well as 
any combination of risk and are 
consistent with the use of the 
devices. Therefore, the devices 
are considered safe for their 
intended use. These risks are 
identified as residual risks and 
are disclosed to the end user. 
Only participants requiring a 
Spinal needle device as part of 
their standard medical care will 
receive a device. The treating 
physician will select the most 
appropriate device for the 
participants based on their 
specific needs. 
The general guidelines “aseptic 
technique and proper 
preparation are essential” and 
“observe universal precautions 
with all patients” are included 
in the BD Spinal NRFit™ 
needles and in the BD Spinal 
NRFit™ Sets IFUs. 
 
Only physicians experienced in 
performing procedures using 
Spinal Needles and Spinal 
Needle Sets should perform 
neuraxial anesthesia 
procedures. A caution 
statement, “To be used by 
properly qualified and trained 
healthcare professionals”, is 
included in the BD Spinal 

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Potential Risk of Clinical 
Significance 
Summary of Data/Rationale 
for Risk 
Mitigation Strategy 
• anterior spinal artery 
syndrome,  
• acute neuropathic pain,  
• damage to CNS blood vessels,  
• AV fistula formation,  
• spinal cord ischemia,  
• permanent neurological injury,  
• paraplegia,  
• hypotension, 
• cardiovascular collapse,  
• death. 
NRFit™ needles and in the BD 
Spinal NRFit™ Sets IFUs. 
See device specific IFU for 
additional information. 
Study Intervention (s): BD Spinal Introducer NRFit™ Needle 
Complications vary based upon 
anatomic site and clinician 
experience and may include:  
• localized/systemic infection,  
• exposure to bodily fluids 
and/or bloodborne pathogens,  
• low back pain, 
• accidental puncture of the 
dura,  
• post dural puncture headache. 
A benefit-risk assessment for 
the overall medical device is 
documented in the Risk 
Management Report.  
All risks and combinations of 
risks were reviewed, and it has 
been determined that all are 
within acceptable limits. The 
benefits of the device outweigh 
each risk individually as well as 
any combination of risk and are 
consistent with the use of the 
devices. Therefore, the devices 
are considered safe for their 
intended use. These risks are 
identified as residual risks and 
are disclosed to the end user. 
Only physicians experienced in 
performing procedures using 
Spinal Introducer Needles 
should perform neuraxial 
anesthesia procedures. A 
caution statement, “To be used 
by properly qualified and 
trained healthcare 
professionals”, is included in 
the BD Spinal Introducer 
NRFit™ needle IFU.  
See device specific IFU for 
additional information. 
Study Intervention (s): BD Syringes NRFit™  
Potential Procedure Related 
Complications: 
• Pain,  
• exposure to bloodborne 
pathogens, 
• potential for 
infiltration/extravasation, 
particulate embolism,  
• air embolism, 
• localized/systemic infection,  
• death. 
A benefit-risk assessment for 
the overall medical device is 
documented in the Risk 
Management Report.  
All risks and combinations of 
risks were reviewed, and it has 
been determined that all are 
within acceptable limits. The 
benefits of the device outweigh 
each risk individually as well as 
any combination of risk and are 
consistent with the use of the 
devices. Therefore, the devices 
considered safe for their 
intended use. These risks are 
identified as residual risks and 
are disclosed to the end user. 
The IFUs report that Syringes 
are intended for neuraxial use 
by healthcare professional. 
The caution statements, 
“Observe syringe carefully 
during procedures” and 
“Always inspect the package 
before opening” are included in 
the BD Syringes NRFit™ IFUs. 
The general guidelines “aseptic 
technique and proper 
preparation are essential” and 
“observe universal precautions 
with all patients” are included 
in the BD Syringes NRFit™ 
IFUs. 
 

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Potential Risk of Clinical 
Significance 
Summary of Data/Rationale 
for Risk 
Mitigation Strategy 
Leakage resulting in an 
inaccurate dose or exposure to 
medicine and bodily fluids. 
 
A general guideline “An ISO 
80369-6 compliant syringe tip 
cap can be used to prevent 
leakage of fluids or medications 
from the syringe” is included in 
the BD Syringes NRFit™ IFUs. 
See device specific IFU for 
additional information. 
Study Procedures 
No study-specific risks identified, 
compared to any neuraxial 
procedure as part of standard 
medical care. Neuraxial 
procedures maybe associated 
with the following risks: 
• Inadequate or failed anesthesia 
• Hemodynamic changes, most 
commonly hypotension 
• Post-dural puncture headache 
• Localized pain 
• Localized skin irritation 
• Urinary retention (temporary) 
• Nerve injury (rare) 
• Spinal-epidural hematoma 
(rare) 
• Infection 
See Clinical literature [10]; 
[11]; [12]; [13]; [14] for 
additional information. 
• Physicians should select the 
smallest diameter needle 
sufficient to support the 
specific procedure 
• Patient blood pressure and 
heart rate should be closely 
monitored throughout the 
procedure and after 
medication administration 
• Only physicians with 
sufficient training and 
experience should perform 
neuraxial anesthesia 
procedures 
Potential procedure 
complications with the ancillary 
devices: 
• Redness 
• Irritation 
• Pain 
• Bleeding 
• Anxiety 
• Syncopal episode 
• Granuloma 
• Hematoma 
• Paresthesia 
• Exposure to bloodborne 
pathogens 
• Potential for 
infiltration/extravasation 
• Particulate embolism 
• Localized/systemic infection 
• Floaters 
 
The warning statements, 
“Aseptic technique and proper 
preparation are essential” and 
“Percutaneous puncture with a 
contaminated needle may lead 
to serious illness, or other 
infectious diseases” are 
included in the Blunt Fill 
NRFit™ Needles and Blunt 
Filter NRFit™ Needles IFUs. 
See device specific IFU for 
additional information. 
 
 

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2.3.2 Benefit Assessment 
There is no direct benefit for study participation for an individual patient other than the 
placement of one of the study devices. 
2.3.3 Overall Benefit: Risk Conclusion 
There is no anticipated additional risk associated with the device use or any study 
procedure due to participation in this study compared to any BD Spinal NRFit™ Needles, 
the BD Spinal Introducer NRFit™ Needles, BD Spinal NRFit™ Needle Sets, and the BD 
Syringes NRFit™ use as part of standard medical care. 
3 OBJECTIVES AND ENDPOINTS 
Objectives 
Endpoints 
Primary Performance 
 
• To assess the performance of the BD Spinal 
NRFit™ needles and BD NRFit™ 
introducers used in spinal anesthesia 
procedures. 
• Percentage of participants with successful 
placement of the BD Spinal NRFit™ needle 
in the subarachnoid location defined as the 
spontaneous appearance of cerebrospinal 
fluid (CSF) emerging from the spinal needle 
hub. 
• Percentage of participants with successful 
placement of the BD Spinal NRFit™ needle 
in the subarachnoid location defined as the 
spontaneous appearance of cerebrospinal 
fluid (CSF) emerging from the spinal needle 
hub when an BD NRFit™ introducer is 
used. 
 
 
• To assess the performance of BD NRFit™ 
Syringes when used in spinal anesthesia 
procedures. 
• Percentage of participants with successful 
aspiration and injection of anesthetic 
through a BD NRFit™ Syringe. 
• Percentage of participants with BD NRFit™ 
Syringes that do not leak at the connection 
point during medication administration. 

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Objectives 
Endpoints 
Primary Safety 
 
• To assess the incidence of post dural 
puncture headache (PDPH). 
 
• Percentage of participants with a diagnosis 
of PDPH (defined as headache that worsens 
when standing/upright position and relieves 
when laying supine) for a period of up to 10 
(± 3 days)* days following the procedure. 
 
 
• To assess the incidence of any BD NRFit™ 
spinal needle and BD NRFit™ introducer 
and BD NRFit™ syringe and procedure-
related adverse events (other than PDPH). 
• Incidence of device/procedure-related 
adverse events. 
*The time window of ± 3 days must be used when the 
10-day post-procedure occurs during the weekends or 
holidays. 
3.1 
Acceptance Criteria 
Acceptance criteria are anticipated for the following objectives: 
• Relevant literature for the state-of-the-art generic device group- spinal needle and spinal 
introducer needle supports the predefined clinical performance objectives, success rate 
in placing the needle in the subarachnoid space and obtaining CSF. Confirmation of the 
spontaneous appearance of cerebrospinal fluid (CSF) emerging from the spinal needle 
hub. The Primary efficacy endpoint is the spontaneous appearance of CSF with the 
expected rate ranging ≥ 90% [15], [16], [17], [18], [19] and [20]. 
• Relevant literature for the state-of-the-art generic device group- spinal needle and spinal 
introducer needle supports the predefined clinical safety objectives, incidence of Post 
Dural Puncture Headache (PDPH) ≤ 3% within 7 days following spinal procedure. In 
the state-of-the-art literature several studies investigated incidence of PDPH, it ranges 
from 0% to 28.12%. All cases occurred within 7 days following the procedure [15], 
[16], [17], [18], [21], [22], [23], [24], [25], [26], [27], [28], [29], [30], [31], [32], [33], 
[34], [35], [36], [37], [38], [39], [40], [41], [42], [43], [44]. 
• Relevant literature for the state-of-the-art generic device group- spinal needle and spinal 
introducer needle supports the predefined clinical safety objectives, preventing 
misconnection and wrong route medication delivery misconnections or wrong route 
administration of medication has prompted the introduction of ISO 80369, NRFit 
needles [45], [46], [47], [48], [49], [50], [51], [52], [53]. 
Other acceptance criteria are:  
• Incidence of misconnection 0% 
• Incidence of medication leak at BD NRFit™ syringe connection point < 2% 
• Incidence of aspiration/injection through a BD NRFit™ syringe > 80% 

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4 STUDY DESIGN 
4.1 
Overall Design 
This is a multi-center, prospective, open label, single arm post-market study that will enroll 
approximately 180 participants in order to have a minimum of 150 treated participants who 
will receive a spinal anesthesia procedure as part of their routine medical care. A minimum 
of 50 participants for each of the two needle tip types (Quincke and Whitacre tip) will be 
enrolled in the study. Data related to the safety and performance of the BD Spinal NRFit™ 
Needles, the BD Spinal Introducer NRFit™ Needles, the BD Spinal NRFit™ Needle Sets, 
the BD Syringes NRFit™ and ancillary devices will be captured when used as intended. 
Participants will be screened against eligibility criteria and will be considered enrolled once 
the informed consent document is signed. The procedure(s) performed, and device(s) used, 
will be left to the discretion of the participant’s physician investigator. 
Participants will be followed from the time of spinal procedure for up to 10 days (± 3 days) 
post spinal procedure to assess for any adverse events/complications. If the participant has 
been discharged from the hospital prior to day-10 (± 3 days) post procedure, follow-up may 
be performed in a variety of ways including by telephone. The site staff must take advantage 
of the time window of ± 3 days only when the 10-day post-procedure occurs during the 
weekends or holidays. However, any adverse event or complication must be diagnosed and 
confirmed by a study physician. 
Additionally, to assess overall ease of spinal procedure, the clinician performing the 
procedure will complete a brief survey describing their experience with the procedure. 
The total duration of the study is expected to be approximately 49-51 weeks from first 
participant enrolled up to last participant having last visit. 
4.2 
Scientific Rationale for Study Design 
This study is designed to collect clinical data on the safety and performance of the BD Spinal 
NRFit™ Needles, the BD Spinal Introducer NRFit™ Needles, the BD Spinal NRFit™ 
Needle Sets, and the BD Syringes NRFit™ devices. The usage of the study and ancillary 
devices, according to its intended use will ensure that study activities have no direct impact 
on the endpoints being assessed and that they represent outcomes typically associated with 
the intended medical use of the study devices in clinical practice. 
4.2.1 Participant Input into Design 
Not applicable. Participant input was not sought while designing the study. 
4.3 
End of Study Definition 
A participant is considered to have completed the study if he/she has completed all phases of 
the study including the day-10 (± 3 days) post procedure follow-up assessment. 
The end of the study is defined as the date of the last study assessment of the last participant 
in the study. 

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5 STUDY POPULATION 
Participants will be recruited from the patient population treated at the investigational sites. 
Sites may choose to limit recruitment to specific areas of the hospital and/or to patients 
treated by specific healthcare providers. 
5.1 
Inclusion Criteria 
In order to be eligible to participate in this study, an individual must meet all of the following 
criteria: 
1. Any patient, regardless of age or gender, for which the investigator has decided that a 
neuraxial procedure must be performed utilizing BD NRFit™ Spinal Needles, 
NRFit™ Spinal Introducer Needles, and NRFit™ Syringes as part of their routine 
medical care. 
2. Expected to be available for observation through the study period (10 days, ± 3 days, 
post procedure*). 
3. Able and willing to provide signed and dated informed consent or legal authorized 
representative (LAR) authorized to give consent on behalf of the participant (Note: 
Consent of guardian or parent may be required for participants under the age of 18 
years; participant assent may be required as well). 
*The time window of ± 3 days must be used when the 10-day post-procedure occurs during the weekends or 
holidays. 
5.2 
Exclusion Criteria 
Participants are excluded from the study if any of the following criteria apply: 
1. Coagulopathy or bleeding disorder, where it is in the opinion of the investigator 
makes regional anesthetic of increased risk. 
2. Subjects with a history of neurological impairment of the trunk or lower extremities. 
3. Infection at the site of needle insertion. 
4. Previous spine surgery at the level involved in the study procedure. 
5.3 
Lifestyle Considerations 
Not applicable. There are no study-specific restrictions other than those typically associated 
with use of a study devices (e.g., keeping the insertion area clean and dry). 
5.4 
Screen Failures 
Screen failures are defined as participants who consent to participate in the clinical study but 
have not subsequently met the eligibility criteria. Data on informed consent, age, sex 
assigned at birth, and reason of screening failure will be collected. Additional information 
may also be collected if appropriate. 
Individuals who do not meet the criteria for participation in this study (screen failure) may 
not be rescreened.  

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5.5 
Vulnerable Population 
As the instruction for use of the BD NRFit™ Spinal Needles, BD Spinal NRFit™ Needle 
Sets, BD NRFit™ Spinal Introducer Needles, and BD NRFit™ Syringes does not foresee any 
limitations in terms of subject age or status and the study aims to collect data on clinical use, 
the study will also consider participants under 18 years of age, or participants requiring a 
legal authorized representative. In addition, pregnant and breastfeeding subjects are not 
excluded from study participation. As the study devices will be used as intended, this 
population is considered to be not exposed to any additional risk due to study participation. 
 
Some participating clinical sites may decide to not include vulnerable subjects as per their 
hospital policy or may not include minors as the participating department treats only adults. 
5.6 
Point of Enrolment 
The time at which, following recruitment and before any study-related procedures are 
undertaken, a participant signs and dates the informed consent form. 
5.7 
Participation duration 
It is expected to take approximately 47 weeks to complete participant enrollment. The total 
duration of the study is expected to be approximately 49-51 weeks from first participant 
enrolled up to last participant having last visit. 
The duration of study participation for an individual subject is expected to be 11 days, ± 3 
days, (from procedure through last visit). 
6 STUDY INTERVENTIONS 
6.1 
Investigational/Test Device 
The BD Spinal NRFit™ Needles (BD Quincke Spinal NRFit™ Needle and BD Whitacre 
Spinal NRFit™ Needle) are intended to gain entry into or puncture the spinal cavity 
permitting injection (including anesthesia) / withdrawal of fluids for purposes of diagnostic 
lumbar puncture and myelography procedures. They consist of a needle, stylet, and needle 
shield and are available in various gauges and needle lengths. The needle consists of a hollow 
needle (cannula) bonded to a translucent hub at one end and a specific needle point type 
(Quincke or Whitacre) at the other end. The stylet has a handle which is color coded and 
correlates to the gauge size.  
The BD Spinal Introducer NRFit™ Needle is intended for placement or introduction of 
spinal needles. The BD Spinal Introducer NRFit™ Needle consists of a needle, needle hub 
and needle shield and is available in various gauges. The needle consists of a hollow needle 
(cannula) bonded to a translucent colored hub (per gauge) at one end and a specific needle 
point type at the other end. The introducer needle is an optional aid through which a spinal 
needle can be inserted. 
The needle hub of the BD Spinal NRFit™ Needles and the BD Spinal Introducer NRFit™ 
Needle incorporates ISO 80369-6 compliant connectors. The needle shields are yellow to 

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indicate that the devices are intended to only connect to ISO 80369-6 (NRFit™) compatible 
devices such as syringes. 
The BD Spinal NRFit™ Needles and the BD Spinal Introducer NRFit™ Needle are sterile, 
non-toxic and non-pyrogenic. These products are not made with natural rubber latex, 
Bisphenol A (BPA) or Di-ethylhexyl Phthalate (DEHP). 
The BD Spinal NRFit™ Needles and the BD Spinal Introducer NRFit™ Needle are to be 
used by properly qualified and trained healthcare professionals. 
The BD Spinal NRFit™ Needle Sets (BD Quincke Spinal NRFit™ Needle Set and BD 
Whitacre Spinal NRFit™ Needle Set) consist of either a BD Quincke Spinal NRFit™ Needle 
or a BD Whitacre Spinal NRFit™ Needle and a BD Spinal Introducer NRFit™ Needle. The 
indications for use, populations for which the devices are intended, and materials remain the 
same of those for the BD Spinal NRFit™ Needles and the BD Spinal Introducers NRFit™ 
Needles. 
The BD Syringes NRFit™ (BD Syringe NRFit™ Lok and BD Syringe NRFit™ Slip) are 
intended for transient use, intended for neuraxial use by healthcare professionals for 
aspiration/injection of fluids.  
They are sterile, single use syringes with ISO 80369-6 (NRFit™) compliant lock or slip 
connectors. The syringe plunger rod is yellow to designate a device intended to only connect 
to ISO 80369-6 compatible devices such as spinal needles. These syringes are non-toxic, 
non-pyrogenic and are not made with natural rubber latex, butylated hydroxytoluene (BHT) 
or Di-ethylhexyl Phthalate (DEHP).  
The BD Spinal NRFit™ Needles, BD Spinal Introducer NRFit™ Needle and BD Syringes 
NRFit™ are intended for adult and pediatric patients.  
Appendix 16.1 provides an overview of the study device variants available for use. 
The BD Spinal NRFit™ Needles, BD Spinal Introducer NRFit™ Needle, the BD Spinal 
NRFit™ Needle Sets, and BD Syringes NRFit™ will be provided by the Sponsor. Devices 
will either be disposed of at the site according to the site’s institutional standard operating 
procedure or returned to the Sponsor with the appropriate documentation. 
Accurate records of all devices received at, dispensed, returned to, and disposed of by the site 
should be recorded on Study Product Accountability Log. 
Aseptic technique and proper preparation are essential for the neuraxial procedure, requiring 
the physician to wear cap, mask, sterile gloves, and sterile gown. The participant will be 
covered with a sterile drape and prepped with an appropriate antiseptic agent per procedures 
guidelines. If a BD Spinal Introducer NRFit™ Needle is used, it is placed between the 
lumbar vertebrae at the desired interspace and angle. The BD Spinal NRFit™ needle 
(Quincke or Whitacre) is then inserted through the Introducer NRFit™ needle. The stylet is 
removed to check for the appearance of CerebroSpinal Fluid (CSF), and then replaced if 
further advancement of the spinal needle is needed. Once the CSF appears to a satisfactory 
degree, the medication is delivered through the BD Syringes NRFit™ (Lok or Slip) into the 
CSF, and the NRFit™ spinal and introducer needles are removed. Site staff may monitor the 
participant for physiologic and medication effects as part of their routine medical care. 

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6.2 
Control Device/Standard of Care 
Not applicable. This is a single-arm study. 
6.3 
Ancillary Devices/Products 
Neuraxial procedures are conducted under strict aseptic technique and require the physician 
to wear cap, mask, sterile gloves, and sterile gown. The participant will be covered with a 
sterile drape and prepped with an appropriate antiseptic agent. Materials used to comply with 
aseptic technique, including the medication for local skin anesthesia, will be provided by the 
site according to their site-specific requirements. These products will be used as part of the 
standard of care of each site. Selected information regarding these products will be collected 
(See Section 7.3). 
Ancillary devices BD Blunt Fill NRFit™ Needles and the BD Blunt Filter NRFit™ Needles 
are used to aspirate desired medication from an ampule or vial and dose into a BD Syringes 
NRFit™. They consist of a hollow needle with a blunt needle point, a needle shield and an 
ISO 80369-6 (NRFit™) compliant, yellow-colored needle hub. The needle hub of the Blunt 
Filter NRFit™ Needle also has a translucent purple/pink colored portion to indicate that the 
device contains a filter, while the Blunt Fill NRFit™ Needle has an opaque, red portion. 
Selected information regarding these devices will be collected (See Section 7.3).  
The BD Blunt Fill NRFit™ Needles and the BD Blunt Filter NRFit™ Needles will be 
provided by the Sponsor. Devices will either be disposed of at the site according to the site’s 
institutional standard operating procedure or returned to the Sponsor with the appropriate 
documentation. 
Accurate records of all devices received at, dispensed, returned to, and disposed of by the site 
will be recorded on Study Product Accountability Log. 
6.4 
Device Labeling 
This study will utilize marketed products.  As such, no special labelling is required. 
However, to ensure that the study devices will be used at the study sites only on behalf of the 
study, the device packaging will be labeled as “For clinical trial use only” and in the 
translated format in local languages. Additional details may be found in the Study Supply 
Plan. 
6.5 
Treatment Allocation and Measures to Minimize Bias 
This is a post-market study in which study devices are used as intended. The choice of the 
specific device is left to the discretion of the clinician. 
All the participants will be proposed the study in chronological order when they attend a 
regular clinic visit, this rule will allow to avoid any selection bias. 
All participants potentially fulfilling the inclusion/exclusion criteria will be sequentially 
offered participation in this study when they attend for a clinical visit prior to performance of 
neuraxial procedure.  

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7 STUDY PROCEDURES AND ASSESSMENTS 
• Study procedures and their timing are summarized in the Schedule of Activities (SoA, 
Section 1.3).  
• Protocol waivers or exemptions are not allowed. 
• Adherence to the study design requirements, including those specified in the SoA, is 
essential and required for study conduct. 
• All inclusion/exclusion criteria must be reviewed to confirm that potential participants 
meet all eligibility criteria. The investigator will maintain a screening log to record details 
of all participants screened and to confirm eligibility or record reasons for screening 
failure, as applicable. The investigator will maintain a subject identification log of all the 
participants enrolled in the study, assigning an identification code linked to their names, 
alternative subject identification or contact information. 
• Procedures conducted as part of the participant’s routine clinical management (e.g., blood 
count) and obtained before signing of the ICF may be utilized for baseline purposes 
provided the procedures met the protocol-specified criteria and were performed within 
the time frame defined in the SoA. 
7.1 
Screening and Enrollment 
After general screening against inclusion/exclusion criteria, potential participants will be 
provided with detailed information about the study. For details on the Informed Consent 
process, please refer to section 14.2. A participant will be considered enrolled once informed 
consent (or assent as applicable) is signed. Enrolled patients will be assigned a unique 
participant number. 
7.2 
Medical History / Demography / Baseline Assessments 
After enrollment, participant baseline and demographic information will be documented, 
including, but not limited to:  
• Age 
• Sex assigned at birth and ethnic origin 
• Height and weight (for calculated body mass index) 
• Limited Medical history including, but not limited to: 
- 
Coagulopathy or bleeding disorder 
- 
History of neurological impairment of the trunk or lower extremities 
- 
Infection at the site of needle insertion 
- 
Previous spine surgery at the level involved in the spinal procedure 
- 
History of chronic or recurring headaches 
- 
Spine deformity (kyphosis/scoliosis) 
• Reason for surgery/intervention (e.g., surgery of lower extremities, surgery of lower 
abdomen) 
• Reason for neuraxial procedure (e.g., analgesia or anesthesia)  

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• American Society of Anesthesiologists (ASA) physical status (PS) classification. See 
appendix 16.2 for the definitions and ASA-approved examples [54]. 
7.3 
Spinal procedure 
Choice of the specific BD Spinal NRFit™ Needle, gauge, length, tip, type and size of a BD 
Syringes NRFit as well as the option of using a BD Spinal NRFit™ Needle set and BD 
Spinal Introducer NRFit™ Needle, required for an individual participant is left to the 
discretion of the clinician. BD Spinal Introducer NRFit™ Needle sizes paired to selected BD 
Spinal NRFit™ Needles may be used. The devices, participant, aseptic technique, and 
insertion site will be prepared according to standard medical practices and site-specific 
procedures.  
Ancillary devices are the BD Blunt Fill NRFit™ Needles and the BD Blunt Filter NRFit™ 
Needles, and they are used to aspirate desired medication from an ampule or vial by 
connecting the needle hub to a NRFit™ syringe, and to dose into a BD Syringes NRFit™. 
If a BD Spinal Introducer NRFit™ Needle is used, it is placed between the lumbar vertebrae 
at the desired interspace and angle. The BD Spinal NRFit™ needle (Quincke or Whitacre) is 
then inserted through the Introducer NRFit™ needle. The stylet is removed to check for the 
appearance of Cerebrospinal Fluid (CSF), and then replaced if further advancement of the 
spinal needle is needed.  
Once the BD Spinal NRFit™ Needle and BD Spinal Introducer NRFit™ Needle, if the latter 
is used, is successfully placed, the procedure will be completed, injecting the medication 
through a BD Syringes NRFit™ into the CSF, and removing the NRFit™ spinal and 
introducer needles. 
The devices will be utilized according to the specific medical needs of the participant and 
site-specific protocols and procedures. 
Residents in training program in anesthesia cannot perform the spinal procedure within the 
study. 
7.3.1 Spinal procedure data 
Information about the spinal procedure will be documented, including, but not limited to: 
• Date and time of NRFit™ Introducer/spinal needle insertion 
• Participant position (e.g., lateral position, sitting position) 
• Aseptic technique  
• Preparation anesthetic medication procedure (e.g., accessories used, including 
Blunt Fill and Blunt Filter NRFit™ Needles) 
• Local anesthetic medication used for local skin anesthesia 
• Lumbar Interspace selected for the procedure* 
• Spinal NRFit™ Needle type, gauge, length, catalog number, expire date and lot 
number 

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• Spinal NRFit™ Introducer, gauge, length, catalog number, expire date and lot 
number (if used) 
• Syringes NRFit™ type, size, catalog number, expire date and lot number 
• Spinal NRFit™ set type, gauge, length, catalog number, expire date and lot 
number 
• Number of spinal needles* 
• Lumbar level at which spinal needle placement was successful 
• Medications/agents injected (type, dose, volume)  
• Maximum spinal block level measured (left and right) (if performed) 
• Adverse events/complications (including but not limited to study endpoints) 
• Device deficiencies/failures 
* Physicians performing the spinal procedure may use more than one spinal NRFit™ 
needle. One reason could be a failure with the device, but frequently it is due to the fact 
that another spinal NRFit™ needle with a different size may be more suitable for that 
particular participant, due to an individual participant anatomy for example. In this 
second case, there is no device failure, just the clinician’s preference to use a different 
needle to achieve procedural success. 
Information about the different spinal NRFit™ needles (type, gauge, and length) utilized 
with the corresponding different interspace levels used during the spinal procedure will 
be also collected with the reason of failure. 
7.3.2 Ease of Use Procedure Survey 
After the spinal procedure has been performed and related data is recorded, the clinician 
performing the procedure will complete a brief survey describing their experience with 
the procedure to assess the performance of the study / ancillary devices used in the 
procedure. 
7.4 
Follow-Up 
Participants will be followed through 10-days (± 3 days) post procedure to assess for adverse 
events/complications. Assessments may be performed in a variety of ways, including by 
telephone, if the participant has been discharged from the hospital prior to day-10 post 
procedure. The site staff must take advantage of the time window of ± 3 days only when the 
10-day post-procedure occurs during the weekends or holidays. Any adverse event or 
complication must be diagnosed and confirmed by a study physician. Additional information 
may also be collected if appropriate.  
7.4.1 Follow-Up data 
During the required follow-up period the following data will be collected: 
• Adverse events/complications 

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• Post-dural puncture headache (PDPH) 
Since there are many causes of headache, it is important that the physicians make the 
diagnosis of Post Dural-Puncture Headache after sufficient evaluation and being 
reasonably certain that is the cause of the headache. Post-dural puncture headache is 
defined as a headache which occurs in the upright/standing position and is relieved when 
the participant is lying down, provided no other cause of headache could be identified. 
PDPH is a headache occurring within 5 days of a lumbar puncture, caused by 
cerebrospinal fluid (CSF) leakage through the dural puncture. It is usually accompanied 
by neck stiffness and/or subjective hearing symptoms. It remits spontaneously within 2 
weeks, or after sealing of the leak with autologous epidural lumbar patch [55].  
Participants will be questioned for the presence, severity, onset, duration, and 
characteristics of headaches, and any other complications. The severity of the headache 
will be graded from none to mild, moderate, or severe as following [56]: 
o None: No PDPH 
o Mild: when PDPH caused no interference with daily activities and was treated 
with no medication or oral analgesics.   
o Moderate: when PDPH caused a patient difficulty in performing daily activities 
and was treated with oral analgesics.   
o Severe: a headache that resulted in the patients being unable to perform his or her 
daily activities or being confined to bed and requiring oral or IV analgesic and/or 
epidural blood patch for treatment. 
8 PARTICIPANT DISCONTINUATION/WITHDRAWAL 
8.1 
Discontinuation/Withdrawal 
• A participant may withdraw from the study at any time at his/her own request or may 
be withdrawn at any time at the discretion of the investigator or sponsor for safety, 
behavioral, compliance, or administrative reasons. This is expected to be uncommon. 
• At the time of discontinuing from the study, no further data will be collected for the 
participant. 
• If the participant withdraws consent from the study, he/she will inform the study 
physician who will record the withdrawal in the source documentation and 
appropriate section of the electronic case report form. 
• If the participant withdraws consent for disclosure of future information, the sponsor 
may retain and continue to use any data collected before such a withdrawal of 
consent. 
• Participants who withdraw or discontinue the study early (e.g., prior to day-10 post 
procedure follow-up or prior the procedure) may be replaced. 
8.2 
Lost to Follow-Up 
A participant will be considered lost to follow-up if he or she repeatedly is unable to be 
contacted by the study site. 

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Before a participant is deemed lost to follow up, the investigator or designee must make 
every effort to regain contact with the participant, where possible, with two telephone calls, 
or a message to the participant’s last known mailing address or local equivalent methods. 
These contact attempts should be documented in the participant’s medical record with 
possible reasons lost to follow-up, if available. 
9 ADVERSE EVENTS AND DEVICE DEFICIENCIES 
9.1 
Definitions of Events 
9.1.1 Adverse Events (AEs) 
An adverse event is defined as any untoward medical occurrence, unintended disease or 
injury, or untoward clinical signs (including abnormal laboratory findings) in 
participants, users, or other persons, whether or not related to the 
investigational medical devices or procedure and whether anticipated or unanticipated 
(ISO 14155:2020). 
Pre-existing conditions should be considered as part of the participant’s medical history 
and should not be reported as an AE unless there is a substantial increase in severity or 
frequency of the condition, which has not been attributed to natural history. Likewise, 
planned hospital visits and/or hospital stays should not be considered as adverse events.  
Exacerbation of an existing condition should be reported as an AE if the event meets the 
protocol definition of an AE. 
The clinical course of the event will be followed according to accepted standards of 
medical practice until the event resolves, stabilizes, or in the opinion of the Investigator, 
is no longer considered clinically significant.  The Investigator must supply the Sponsor 
with information concerning the follow up and/or resolution of the AE. 
9.1.2 Serious Adverse Events (SAEs) 
A serious adverse event is defined by ISO 14155:2020 as an adverse event that led to any 
of the following:  
a. death;  
b. serious deterioration in health of the participant, users, or other persons as 
defined by one or more of the following:  
1. a life-threatening illness or injury, or 
2. a permanent impairment of a body structure or a body function including 
chronic diseases, or 
3. in-patient or prolonged hospitalization, or  
4. medical or surgical intervention to prevent life-threatening illness or injury or 
permanent impairment to a body structure or a body function, 
c. fetal distress, fetal death, or a congenital abnormality or birth defect including 
physical or mental impairment. 
Planned hospitalization for a pre-existing condition, or a procedure required by the 
protocol, without serious deterioration in health, is not considered a serious adverse 
event. 

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9.1.3 Adverse Device Effect (ADE) / Serious Adverse Device Effect (SADE) 
An adverse device effect is defined as any adverse event that is considered to be related 
to the use of an investigational medical device. This definition includes any event 
resulting from insufficiencies or inadequacies in the instructions for use, deployment, 
implantation, installation or operation or any malfunction of the investigational device 
(study device) and includes any event that is a result of a user error or intentional misuse 
of the investigational medical device. 
A serious adverse device effect (SADE) is defined as an ADE that has resulted in any of 
the consequences characteristic of an SAE. 
9.1.4 Unanticipated (Serious) Adverse Device Effect (UADE/USADE) 
An unanticipated (serious) adverse device effect (UADE/USADE) is any (serious) 
adverse device effect on health or safety or any life-threatening problem or death caused 
by, or associated with, a study device, which by its nature, incidence, severity, or 
outcome has not been identified in the current instructions for use and/or current version 
of the risk analysis report, or any other unanticipated serious problem associated with a 
device that relates to the rights, safety or welfare of participants. 
UADEs/USADEs will be reported to the appropriate governing body per ISO 
14155:2020. 
Anticipated serious adverse device effect (ASADE) is an effect which by its nature, 
incidence, severity or outcome has been identified in the risk assessment. 
9.2 
Severity of Adverse Events 
Each AE shall be assessed for its severity, or the intensity of an event, experienced by the 
participant according to the criteria below. 
Severity Rating 
Description 
Mild 
Event, signs, or symptoms that do not interfere with the participant’s 
daily activity, are usually considered self-limiting, can be treated 
with non-prescription type medications, and do not require medical 
intervention 
Moderate 
Event may interfere or cause low level inconvenience with the 
participant’s daily activity. Requires medical intervention and/or 
treatment; however, unlikely to require hospitalization or be 
considered potentially life-threatening in nature 
Severe 
Event may cause significant discomfort to the participant and/or 
interferes with the participant’s daily activity. Requires medical 
intervention and/or treatment to preclude a permanent impairment; 
may be life threatening and/or require hospitalization 
9.3 
Relationship of Adverse Event to Device(s)/Procedure 
Each AE will be assessed for its relationship to the study device or procedure according to 
the following guidelines. 

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A.  Assess each AE for its relationship to the device or procedure. 
• Device Related: This category should be restricted to AEs directly attributable to 
the study devices used. 
• Procedure: A procedure includes any study-related activity performed during the 
neuraxial procedure.  
 
B.  The following categories shall be used for assigning the certainty of the relatedness. 
Relatedness 
Description according to MDCG 2020-10/1 
Not Related 
Relationship to the device, comparator or procedures can be 
excluded when: 
• The event has no temporal relationship with the use of the 
investigational device, or the procedures related to application 
of the investigational device; 
• The AE/SAE does not follow a known response pattern to the 
medical device (if the response pattern is previously known) and 
is biologically implausible; 
• The discontinuation of medical device application or the 
reduction of the level of activation/exposure - when clinically 
feasible - and reintroduction of its use (or increase of the level 
of activation/exposure), do not impact on the AE/SAE; 
• The event involves a body-site or an organ that cannot be 
affected by the device or procedure; 
• The AE/SAE can be attributed to another cause (e.g. an 
underlying or concurrent illness/ clinical condition, an effect of 
another device, drug, treatment or other risk factors); 
• The event does not depend on a false result given by the 
investigational device used for diagnosis^, when applicable; 
 
In order to establish the non-relatedness, not all the criteria listed 
above might be met at the same time, depending on the type of 
device/procedures and the serious adverse event. 
 
^If an investigational device gives an incorrect diagnosis, the patient might, for 
example, receive an unnecessary treatment and incur all the risks that 
accompany that treatment, or might be incorrectly diagnosed with a serious 
disease. In other cases, the patient might not receive an effective treatment 
(thereby missing out on the benefits that treatment would confer) or might not 
be diagnosed with the correct disease or condition. 
Possible 
The relationship with the use of the investigational device or 
comparator, or the relationship with procedures, is weak but 
cannot be ruled out completely. Alternative causes are also 
possible (e.g., an underlying or concurrent illness/ clinical 
condition or/and an effect of another device, drug, or treatment). 
Cases where relatedness cannot be assessed, or no information has 
been obtained should also be classified as possible. 

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Relatedness 
Description according to MDCG 2020-10/1 
Probable 
The relationship with the use of the investigational device or 
comparator, or the relationship with procedures, seems relevant 
and/or the event cannot be reasonably explained by another cause. 
Causal 
relationship 
The AE/SAE is associated with the investigational device, 
comparator or with procedures beyond reasonable doubt when: 
• The event is a known side effect of the product category the 
device belongs to or of similar devices and procedures; 
• The event has a temporal relationship with investigational 
device use/application or procedures; 
• The event involves a body-site or organ that 
o the investigational device or procedures are applied to; 
o the investigational device or procedures have an effect on; 
• The AE/SAE follows a known response pattern to the medical 
device (if the response pattern is previously known); 
• The discontinuation of medical device application (or reduction 
of the level of activation/exposure) and reintroduction of its use 
(or increase of the level of activation/exposure), impact on the 
AE/SAE (when clinically feasible); 
• Other possible causes (e.g. an underlying or concurrent illness/ 
clinical condition or/and an effect of another device, drug or 
treatment) have been adequately ruled out; 
• Harm to the subject is due to error in use; 
• The event depends on a false result given by the investigational 
device used for diagnosis^^, when applicable; 
 
In order to establish the relatedness, not all the criteria listed above 
might be met at the same time, depending on the type of 
device/procedures and the serious adverse event. 
 
^^If an investigational device gives an incorrect diagnosis, the patient might, for 
example, receive an unnecessary treatment and incur all the risks that 
accompany that treatment, or might be incorrectly diagnosed with a serious 
disease. In other cases, the patient might not receive an effective treatment 
(thereby missing out on the benefits that treatment would confer), or might not 
be diagnosed with the correct disease or condition. 
9.4 
Reporting of Events 
For all adverse events, all sections of the appropriate Case Report Form (CRF) must be 
completed, reporting the date of the adverse event, resolution, action taken, assessment of 
both the seriousness and the relationship to the study devices and the related procedure 
Additional information may also be collected if appropriate. 
• All SAEs, SADEs, and/or UADEs/USADEs must be reported to the Sponsor via 
electronic CRF without unjustified delay and within three (3) calendar days of the 
site/investigator becoming aware of the event.   

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• De-identified copies of all requested relevant documentation should be submitted to 
the Sponsor within 72 hours of knowledge, as appropriate.  
• Only in case the eCRF system is not operational, the SAEs and (U)SADEs can be 
sent to the Sponsor per e-mail to the e-mail address MDS.ClinicalSafety@bd.com 
• Safety related correspondence or questions can be addressed to following contact. 
BD Trial Safety Team, email: MDS.ClinicalSafety@bd.com  
It is the responsibility of the Investigator to report adverse events to individual Institutional 
Review Boards (IRBs)/Ethics Committees (ECs) and/or regulatory authorities according to 
the local regulations in each participating country. The Sponsor or their designee is 
responsible for reporting AEs to regulatory authorities according to the local regulations in 
each participating country. 
9.5 
Safety Committees 
A safety committee will not be used for this study. 
9.6 
Device Deficiencies 
The Investigator will record a device deficiency if a device used in the study, which appeared 
to be inadequate with respect to its identity, quality, durability, reliability, usability, safety or 
performance whether due to mechanical failure, malfunction, or defect.  Device deficiencies 
also include use errors and inadequate labeling.  This applies to: devices used to treat the 
participant, or devices in which the package was opened, but the device was not used for 
treatment, or devices with which treatment was attempted, but the device did not remain 
through the entire study procedure/period. 
All device deficiencies will be recorded on the appropriate Case Report Form and will be 
promptly reported to the Sponsor. The device(s) should be returned to the Sponsor if 
requested. 
If the device deficiency was associated with an AE, the reporting provisions for AEs, 
ADEs, SAEs, SADEs and UADEs/USADEs apply. 
Reported deficiencies will be investigated and reported under 21 CFR part 803 Medical 
Device Reporting by the Sponsor if necessary, or as required by appropriate national laws 
and regulations. The site may be contacted to provide additional information to allow the 
Sponsor to conduct a thorough investigation. 
It is the responsibility of the Investigator to notify the IRB/EC of such device deficiencies in 
accordance with the IRB/EC and/or the Competent Authority’s local regulations. 
9.7 
Serious Health Threat 
During the course of the study, device deficiencies or adverse events will be assessed if they 
constitute a serious health threat. The serious health threat is a signal from any adverse event 
or device deficiency that indicates an imminent risk of death or a 
serious deterioration in the health in subjects, users or other persons, and that requires prompt 
remedial action for other subjects, users or other persons. Serious health threat includes the 

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possibility of multiple deaths occurring at short intervals, or other significant and unexpected 
serious adverse events that can be regarded as a potential serious health hazard in subjects, 
users or other persons and which are possibly related to the investigation device use. 
10 STATISTICAL METHODS 
The statistical analysis plan will be finalized prior to database lock and will include a more 
technical and detailed description of the statistical analyses described in the following sections. 
This section includes a summary of the planned statistical analyses of the most important 
endpoints including primary endpoints. 
10.1 Overview of Study Design 
This is a multi-center, prospective, post-market study to assess the safety and performance of 
marketed BD NRFit™ Spinal Needles, the BD Spinal Introducer NRFit™ Needles, the BD 
Spinal NRFit™ Needle Sets, and the BD Syringes NRFit™. 
10.2 Sample Size Considerations 
The planned sample size is approximately 150 subjects treated with BD NRFit™ Spinal 
Needle and BD NRFit™ Syringe, and approximately 100 subjects treated with BD NRFit™ 
Spinal Introducer. The sample size is based on the precision of endpoint estimates as well as 
the ability to detect adverse events. For a given endpoint with 90% rate, a sample size of 150 
would lead to a precision of 4.8%, a sample size of 100 would lead to a precision of 6.0%. 
Table 1 below contains further detail. For an adverse event with 1% rate, there is a 
probability of 77.9% to observe at least 1 event in a sample of 150. 
Table 1: Sample Size and Precision 
Sample Size 
Rate 
Precision (Half width of 95% CI) 
150 
90% 
4.8% 
100 
90% 
6.0% 
150 
80% 
6.4% 
150 
3% 
3.1% 
150 
2% 
2.7% 
10.3 Analysis Population 
The following populations are defined: 
Population 
Description 
Enrolled  
All participants who sign the ICF 
Treated 
All participants in whom a spinal anesthesia procedure is attempted, 
regardless of success  
Safety  
All participants in whom a spinal anesthesia procedure is successful 
The primary performance endpoints analysis will be performed on the treated population. 
The primary safety endpoint analysis for PDPH incidence will be performed on the safety 
population. The primary safety endpoint analysis for device/procedure-related adverse events 
(other than PDPH) will be performed on the treated population. 

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10.4 General Considerations 
Study endpoints may be missing due to reasons including lost to follow-up visits, procedures 
not being performed, or participant discontinuation. It is essential to minimize missing data 
and always record why it is missing. Analyses will be performed using evaluable data, 
combining all investigational sites. Statistical output will be generated using SAS (SAS 
Institute, Cary, NC) version 9.4 or above. 
10.5 Primary Endpoint(s) 
10.5.1 Primary Performance Endpoints 
10.5.1.1 Performance of the BD Spinal NRFit™ Needle and BD NRFit™ 
Introducer 
• Rate of successful BD Spinal NRFit™ Needle placement 
The successful placement of the BD Spinal NRFit™ needle in the subarachnoid location 
is defined as the spontaneous appearance of cerebrospinal fluid (CSF) emerging from the 
spinal needle hub. In case of multiple attempts, successful placement is determined by the 
last attempt.  
• Rate of successful BD Spinal NRFit™ Needle placement when a BD Spinal 
NRFit™ Introducer is used 
The successful placement of the BD Spinal NRFit™ needle in the subarachnoid location 
is defined as the spontaneous appearance of cerebrospinal fluid (CSF) emerging from the 
spinal needle hub for subjects who used BD NRFit™ introducer. In case of multiple 
attempts, successful placement is determined by the last attempt. If a subject uses BD 
NRFit™ introducer for the last attempt, the subject will be considered as part of the 
introducer population. 
The incidence rate for the primary performance endpoints will be calculated as the 
number of participants experiencing the event divided by the total number of treated 
participants; 95% confidence interval (exact method) will be calculated.   
10.5.1.2 Performance of the BD NRFit™ Syringes 
• Rate of successful aspiration and injection of anesthetic through BD NRFit™ 
Syringes  
• Rate of BD NRFit™ Syringes that do not leak at the connection point during 
medication administration 
The incidence rate for the primary performance endpoints will be calculated as the 
number of participants experiencing the event divided by the total number of treated 
participants; 95% confidence interval (exact method) will be calculated.   
10.5.2 Primary Safety Endpoints 
• Incidence of post dural puncture headache (PDPH)  

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The event of PDPH is defined as headache that worsens when standing/upright position 
and relieves when laying supine for a period of up to 10 (± 3 days) days following the 
procedure. 
The incidence rate for the above primary safety endpoints will be calculated as the 
number of participants experiencing the event divided by the total number of safety 
participants; 95% confidence interval (exact method) will be calculated.   
• Incidence of any BD NRFit™ spinal needle and BD NRFit™ introducer and BD 
NRFit™ syringe and procedure-related adverse events (other than PDPH) 
The incidence rate for the above primary safety endpoints will be calculated as the 
number of participants experiencing the event divided by the total number of treated 
participants; 95% confidence interval (exact method) will be calculated. 
10.6 Other Analyses 
For other data not specifically captured under primary endpoints, summary statistics for 
categorical variables will include frequency counts and proportions and for continuous 
variables mean, standard deviation, minimum, median and maximum. Further details will be 
included in the final Statistical Analysis Plan (SAP). 
11 DATA COLLECTION AND RECORD MAINTENANCE 
11.1 Case Report Forms 
The Investigator is responsible for ensuring the completeness and accuracy of all study 
documentation. 
All required clinical data will be collected/documented in sponsor-provided electronic Case 
Report Forms (CRFs). Applicable national and local regulations are followed on the handling 
of electronic data. Modification of the CRFs will only be made if deemed necessary by the 
Sponsor and/or the appropriate regulatory body. The site must complete the eCRFs according 
to the participant’s visit on an ongoing basis to allow regular review by the Sponsor or their 
designee, within approximately three (3) days of the site/investigator is aware of the data. 
Site numbers and participant numbers will be used to track participant information 
throughout the study. Participant personal information will be pseudonymized/de-identified.  
11.2 Source Documentation 
Original or certified copies of all relevant clinical findings, observations, and other activities 
throughout the clinical investigation must be recorded and maintained in the medical and/or 
study file of each enrolled participant.  
11.3 Data Management 
Data management is the responsibility of the Sponsor or their designee.  Data from 
completed CRFs will be managed in a secured, controlled database. A Data Management 
Plan (DMP) will be developed that outlines the procedures used for recording, data tracking, 
data review, database cleaning, issuing/resolving data queries and database lock. Procedures 

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for rectifying errors and omissions, verification, validations and securing of the electronic 
data system as well as data storage will also be contained within the DMP. The procedure to 
maintain and protect the participants data privacy and information on data storage upon 
completion of the study will be detailed in the DMP too.   
11.4 Record Retention 
The Investigator shall retain all study records for a minimum of ten (10) years after the study 
termination. Study records may be stored longer if required by national law or other local 
rules.  The data for some of these records may be available in computerized form but the 
final responsibility for maintaining study records remains with the Investigator. No records 
may be destroyed during the retention period without the written approval of the Sponsor. 
The Investigator may withdraw from the responsibility to maintain records for the period 
required by transferring custody of the records to any other person who will accept 
responsibility for retaining them. Notice of a transfer shall be given to the Sponsor not later 
than ten (10) working days after the transfer occurs. 
12 QUALITY CONTROL AND ASSURANCE 
12.1 Control of Study Products 
In this post-market study, marketed devices will be used, provided by the Sponsor. No 
special controls are required in this study. Study products will be released only for use by 
Investigators who have obtained written IRB/EC approval (as required) for participation in 
this study, who have completed all required study documentation, and who have been 
qualified by the Sponsor.  Investigators must maintain control over all study products, and 
ensure they are used in accordance with this protocol.  Failure to do so may result in the 
Sponsor suspending or terminating the study at the Investigator’s site.  
The Investigator will ensure that study products are only dispensed to participants properly 
enrolled in the study. The Investigator must maintain records of receipt, disposition, return 
and/or destruction of all study products. All study products released to the site must be 
accounted for at the unit level prior to study close out, regardless of disposition.  The 
Sponsor-Monitor will regularly review all records regarding study product accountability.  
The Sponsor will maintain records that document the shipment, receipt, disposition, return 
and/or destruction of study products. Additional details may be found in the Study Supply 
Plan. 
12.2 Monitoring 
The Sponsor will designate trained and qualified personnel to monitor the progress of this 
clinical study in accordance with established standard operating procedures and the study-
specific Monitoring Plan.   
Prior to study start, a study initiation visit (SIV) will be conducted to review with the 
Investigator(s) and staff the provisions and proper conduct of this study. This visit will 
include a detailed review of this protocol, verification that all necessary documents are on 
file at the investigational site and confirmation of IRB/EC approvals.   

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During the study, routine monitoring visits (RMVs) will be conducted to assure the site 
continues to adhere to the protocol, the investigator agreement, and regulations regarding 
conduct of clinical studies.  The Sponsor-Monitor will confirm that the ICF to be used is the 
version approved by the IRB/EC, confirm the applicable national privacy laws have been 
followed, verify that all necessary documents are on file at the investigational site and 
confirm that there are provisions to continue and maintain all documents and records 
throughout the study as required by applicable regulations. These monitoring visits will 
assess continued protocol compliance, adequate participant enrollment, accurate data 
reporting, monitoring of participant safety through identification and/or review of any 
device-related AEs, UADEs, or SAEs, device accountability, continued maintenance and 
calibration of study-specific equipment (if applicable), and continued IRB/EC acceptance of 
the study. 
At the completion of the study, the Sponsor-Monitor will conduct a final close-out visit or 
COV. The purpose of this visit may include but is not limited to collecting all outstanding 
study data documents, confirming that the Investigator’s files are accurate and complete, 
reviewing the record retention requirements with the Investigator, providing for the return of 
unused devices to the Sponsor, reviewing records which account for device shipments and 
ensuring that all applicable requirements for closure of the study are met.  
12.3 Audits and Inspections 
If the study is selected for audit by the Sponsor or if there is an inspection by the appropriate 
Health Authorities, the Investigator and her/his team will make themselves available during 
the visit.  The Investigator must agree to the inspection of all study related records and give 
the auditor/inspector direct access to source documents for verification of data on CRFs.  The 
participant’s anonymity must be ensured, and data checked during the audit must remain 
confidential. 
As soon as the Investigator is aware of an upcoming inspection/audit by the Health 
Authorities, he/she will promptly inform the Sponsor.  As agreed with the Investigator, 
Sponsor personnel may be present at the site during the inspection. 
12.4 Protocol Deviations 
A protocol deviation is defined as an event where the Investigator or site personnel did not 
conduct the study according to the protocol. 
Except when necessary to protect the life or physical well-being of a participant, protocol 
deviations are not permitted.  The Sponsor and the investigational site’s IRB/EC must be 
notified immediately if an emergency situation arises in which the safety of a participant may 
require immediate intervention different than that defined in the protocol.  This must be 
followed by written confirmation that describes the emergency action and outcomes, within 
five (5) working days from the date of the emergency action in accordance with the 
governing IRB/EC’s requirement.   
It is the Investigator’s responsibility to ensure that there are no deviations from the Protocol. 
Except in an emergency, when a protocol deviation is planned or anticipated, the Sponsor 
should be contacted for approval.  All deviations must be recorded on the appropriate CRF 
regardless of whether medically justifiable or sponsor approved.  Upon evaluation by the 

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Sponsor, actions may be required to prevent additional deviations, such as retraining of the 
site, implementation of additional site procedures, and more frequent monitoring.  If these 
steps fail, more serious measures, up to and including termination of enrollment at the site, 
may be implemented. 
13 ADMINISTRATIVE REQUIREMENTS 
13.1 Investigator and Site Selection 
The Investigator must be of good standing as an Investigator and knowledgeable in relevant 
areas of clinical research to ensure adherence to the requirements of this protocol, including 
the protection of human participants.  Other site personnel must have appropriate research 
experience and infrastructure to ensure adherence to this protocol and enrollment of 
sufficient numbers of evaluable participants. The curriculum vitae (CV) of the 
Investigator(s), Sub-Investigator(s) and Study Coordinator(s) will be maintained in the 
Sponsor’s files as documentation of qualification by training and experience. 
The Principal Investigator will sign the Investigator Agreement pages of this protocol, 
agreeing to comply with all applicable regulations and the requirements of this study as per 
the clinical study agreement. 
Any site that is deactivated prior to initial enrollment, either by the Sponsor or by the 
individual site itself, may be replaced. 
13.2 Training 
Each Investigator and appropriate site personnel will be trained on this protocol and study 
procedures during the Site Initiation Visit and on the study device, if needed.  
All training will be documented and filed at the investigational site and with the Sponsor. 
13.3 Required Documents 
An Investigator may not screen or enroll participants until authorized to do so by the 
Sponsor. At a minimum, the following documentation should be received by the Sponsor 
prior to the commencement of study activities: 
• Fully executed Non-disclosure Agreement (NDA) between PI/site and Sponsor; 
• CVs, signed and dated within 2 years of study start for the PI and Sub-Investigator(s); 
• CVs for Study Coordinator(s); 
• Signed Clinical Study Agreement (CSA) by PI/site (or designee); 
• Signed Investigator Agreement Page by PI and Sub-Investigator(s); 
• Signed Financial Disclosure Statement by PI and Sub-Investigator(s); 
• Completed and Signed Training Log by PI and Sub-Investigator(s); 
• Study Personnel Identification list; 
• Written approval from the IRB/EC of both the protocol and ICF, and any other 
applicable protocol specific material; and 

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• IRB/EC Membership List, Assurance of Compliance Form, or equivalent. 
13.4 Insurance 
Where required by local regulation, insurance coverage will be provided by BD for study 
participants. 
13.5 Publication Policy 
The sponsor believes that results of applicable clinical studies should be published in peer-
reviewed literature in a timely, accurate, complete and balanced manner, regardless of study 
outcomes, whenever possible.  As such, at the conclusion of this study, an article may be 
prepared for publication in a reputable scientific journal.  Formal presentation(s) or 
publication(s) of data collected from this study will be considered as a joint publication by 
the investigator(s) and the appropriate personnel of the Sponsor. Authorship will be based on 
generally accepted criteria of the ICMJE (International Committee of Medical Journal 
Editors) and determined by mutual agreement. 
The publication of the principal results from any single-center experience within the study is 
not allowed until the preparation and publication of the multicenter results. Exceptions to this 
rule require the prior approval of the Sponsor. The analysis of other pre-specified and non-
pre-specified endpoints will be performed by the Sponsor or its designee. Such analyses, as 
well as other proposed investigations or manuscripts will require the approval of the Sponsor. 
13.6 Study Registration 
While this is a not an Applicable Clinical Trial and does not meet the FDA Amendments Act 
of 2007 (FDAAA) criteria for clinical study registration, the study will be registered on 
www.clinicaltrials.gov to ensure transparency.  The study will also be registered on 
additional local registries, if applicable. The content of the publicly accessible database(s) 
will be updated throughout the conduct of the clinical study and the results will be entered 
after study completion. 
13.7 Termination of Study 
The Sponsor reserves the right to suspend enrollment or terminate the study at any time 
for any reason. If suspicion of an unacceptable risk, including serious health threat to 
subjects, arises during the study, the Sponsor may suspend the study while the risk is 
assessed. The sponsor shall terminate the clinical investigation if an unacceptable risk which 
cannot be controlled is confirmed.  
Additionally, the Sponsor may suspend enrollment or terminate the study at a specific 
investigational site for reasons including, but not limited to, inadequate data collection, low 
participant enrollment rate, achievement of the total enrollment, conditions imposed by the 
reviewing IRB/EC and/or non-compliance with this protocol or other clinical research 
requirements. Written notice will be submitted to the Investigator in advance of such 
termination.  

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In the event of study suspension or termination, the Sponsor will send a report outlining the 
circumstances to the IRB/EC, and all Investigators and Regulatory Authorities as required by 
regulation.  
14 ETHICAL AND REGULATORY CONSIDERATIONS 
14.1 IRB/EC Approval 
Sponsor or designees must submit the study protocol, Informed Consent Form (if applicable), 
and all other locally required documentation to an appropriate IRB/EC and obtain study-
specific written approval (favorable opinion) before Investigators being allowed to 
participate in the study. Before commencement of the study, the Investigator or designee 
must provide the Sponsor with written documentation of such approval.  The IRB/EC must 
give written renewal of the original approval at least annually to continue the study, if 
applicable per local regulation. In this case, a copy of the written renewal must be provided 
to the Sponsor. 
The IRB/EC will be notified of any amendments to the protocol, as well as possible 
associated information and consent form changes, where applicable, and written approval 
(favorable opinion) will be obtained prior to implementation, as applicable. 
The Investigator or designee is responsible for fulfilling any conditions of approval imposed 
by the IRB/EC, such as regular safety reporting, study timing, etc. The Investigator or 
designee will provide the Sponsor with copies of such reports. 
14.2 Informed Consent and Confidentiality 
Prior to any study procedure, the Investigator (or designee) must explain to each participant 
in layman’s terms, the nature of the study, its purpose, expected duration, and the risks and 
benefits of study participation. For participants under the age of 18, participants’ 
parent(s)/guardian must provide their informed consent and the child must provide assent, 
depending on local EC requirements, by personally signing and dating the respective consent 
form prior to begin of this study. For adult participants, where the participant is not able to or 
not capable to give informed consent, the legal representative will be asked to give consent 
on behalf of the participant. However, the participant will also be informed about the study 
within his/her ability to understand.  
Also, participant will be informed of uses and disclosures of their medical information for 
research purposes, and their rights to access information about them. All applicable national 
privacy laws (e.g., General Data Protection Regulation [GDPR] requirements in the EU) will 
be followed in this study. The participants must be informed of their right to withdraw from 
the study at any time and for any reason without sanction, penalty, or loss of benefits to 
which they are otherwise entitled, and that withdrawal from the study will not jeopardize 
their future medical care. Participants will be informed of their right to new information 
and/or findings relating to the clinical study, and the process by which this information is 
made available. After this explanation, given sufficient time to decide whether to participate, 
before any study procedure is conducted, and before entering the study, the participant must 
voluntarily provide consent by signing, dating and timing the form personally in accordance 
with ISO 14155:2020(E). The participant will receive a copy of his/her signed ICF. The 

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Informed Consent process has to be documented in the participant’s medical records. If new 
information becomes available that may significantly affect the subject’s health status, then 
this information will be provided in written form. Re-consent will be obtained if this is 
considered as necessary. 
The above requirements also apply with respect to informed consent obtained from 
participant’s legally authorized representative. 
14.2.1 Confidentiality 
Participant confidentiality must be strictly held in trust by the Investigator, study staff, 
and the Sponsor.  Participant confidentiality and anonymity will be maintained by 
removal of identifiers from any data, documentation, or clinical samples submitted to the 
Sponsor. 
Any data collected meeting the definition of protected/confidential health information or 
personal identifying information will be collected and maintained using the designated 
authorizations and following privacy procedures as specified in the applicable health 
authority regulations including the European Union General Data Protection Regulation 
(GDPR).  
The Sponsor-Monitor, authorized representatives of the sponsor, and/or applicable Health 
Authorities may inspect all documents and records required to be maintained by the 
Investigator.  The Investigator/Site will permit access to such records.  
14.3 Regulatory Status 
The study devices are CE marked and will be studied in a post-market fashion in Europe. 
14.4 Statement of Compliance 
This clinical investigation will be conducted in compliance with the protocol and following 
regulatory requirements: 
• ISO 14155:2020 (Good Clinical Practice); 
• EU MDR (Council Regulation 2017/745 of 5 April 2017); 
• Ethical principles that have their origin in the Declaration of Helsinki; and 
• Applicable sections of the national laws and regulations. 
The clinical investigation will not commence at a clinical site until approval (favorable 
opinion) from the respective IRB/EC has been received. All additional requirements imposed 
by the IRB/EC(s) will be followed. Involvement of the national competent authorities (e.g. 
by notification, seeking authorization) will be accomplished as required by national laws and 
regulations. 
Where required by local or national regulation, the Sponsor will provide product liability 
insurance for the participants included in the study. The investigator (and/or, as appropriate, 
the hospital administrative representative) and the sponsor will sign a clinical study 
agreement prior to the start of the study, outlining overall sponsor and investigator 

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responsibilities in relation to the study. Financial remuneration will cover the cost per 
included participant, and the specified terms of payments will be described in the contract. 
 
 

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Protocol Number: MDS-21NRFit001 
 
CONFIDENTIAL 
Version: 2.0 
Date: 10JAN2023 
Page 53 of 56 
16 APPENDICES 
16.1 Study devices 
Catalog 
number Product Type 
Product Description 
400220 
BD Whitacre Spinal NRFit™ Needle 
25G × 4.06ʺ (0.50 × 103.2 mm) 
400221 
BD Whitacre Spinal NRFit™ Needle 
25G × 4.70ʺ (0.50 × 119.1 mm) 
400222 
BD Whitacre Spinal NRFit™ Needle 
27G × 4.06ʺ (0.40 × 103.2 mm) 
400223 
BD Whitacre Spinal NRFit™ Needle 
27G × 4.70ʺ (0.40 × 119.1 mm) 
400978 
BD Whitacre Spinal NRFit™ Needle 
22G × 3.50ʺ (0.70 × 88.9 mm) 
400979 
BD Whitacre Spinal NRFit™ Needle 
24G × 3.50ʺ (0.55 × 88.9 mm) 
400980 
BD Whitacre Spinal NRFit™ Needle 
25G × 3.50ʺ (0.50 × 88.9 mm) 
400982 
BD Whitacre Spinal NRFit™ Needle 
27G × 3.50ʺ (0.40 × 88.9 mm) 
400063 
BD Quincke Spinal NRFit™ Needle 
25G × 3.00ʺ (0.5 × 76.2 mm) 
400065 
BD Quincke Spinal NRFit™ Needle 
18G × 3.00ʺ (1.2 × 76.2 mm) 
400070 
BD Quincke Spinal NRFit™ Needle 
18G × 3.50ʺ (1.2 × 88.9 mm) 
400072 
BD Quincke Spinal NRFit™ Needle 
22G × 1.50ʺ (0.7 × 38.1 mm) 
400073 
BD Quincke Spinal NRFit™ Needle 
22G × 2.50ʺ (0.7 × 63.5 mm) 
400077 
BD Quincke Spinal NRFit™ Needle 
22G × 3.00ʺ (0.7 × 76.2 mm) 
400079 
BD Quincke Spinal NRFit™ Needle 
22G × 3.50ʺ (0.7 × 88.9 mm) 
400086 
BD Quincke Spinal NRFit™ Needle 
25G × 2.00ʺ (0.5 × 50.8 mm) 
400089 
BD Quincke Spinal NRFit™ Needle 
25G × 3.50ʺ (0.5 × 88.9 mm) 
400215 
BD Quincke Spinal NRFit™ Needle 
18G × 6.00ʺ (1.20 × 152.4 mm) 
400216 
BD Quincke Spinal NRFit™ Needle 
20G × 6.00ʺ (0.90 × 152.4 mm) 
400217 
BD Quincke Spinal NRFit™ Needle 
22G × 5.00ʺ (0.70 × 127 mm) 
400218 
BD Quincke Spinal NRFit™ Needle 
22G × 7.00ʺ (0.70 × 177.8 mm) 
400219 
BD Quincke Spinal NRFit™ Needle 
25G × 4.70ʺ (0.50 × 119.1 mm) 
400925 
BD Quincke Spinal NRFit™ Needle 
19G × 3.00ʺ (1.1 × 76.2 mm) 
400926 
BD Quincke Spinal NRFit™ Needle 
19G × 3.50ʺ (1.1 × 88.9 mm) 
400927 
BD Quincke Spinal NRFit™ Needle 
20G × 1.50ʺ (0.9 × 38.1 mm) 
400928 
BD Quincke Spinal NRFit™ Needle 
20G × 3.00ʺ (0.9 × 76.2 mm) 
400929 
BD Quincke Spinal NRFit™ Needle 
20G × 3.50ʺ (0.9 × 88.9 mm) 
400930 
BD Quincke Spinal NRFit™ Needle 
23G × 3.50ʺ (0.6 × 88.9 mm) 
400931 
BD Quincke Spinal NRFit™ Needle 
26G × 3.50ʺ (0.45 × 88.9 mm) 
400932 
BD Quincke Spinal NRFit™ Needle 
27G × 3.50ʺ (0.4 × 88.9 mm) 
400177 
BD Spinal Needle Introducer NRFit™ 
20G × 1.25" (0.90 × 31.8 mm) 
400919 
BD Spinal Needle Introducer NRFit™ 
22G × 1.25" (0.70 × 31.8 mm) 
400227 
BD Whitacre Spinal NRFit™ Needle with introducer set 
27G × 3.50ʺ (0.40 × 88.9 mm) + 
22G x 1.25” (0.70mm x 31.8mm) 
400228 
BD Whitacre Spinal NRFit™ Needle with introducer set 
25G × 3.50" (0.50 × 88.9 mm) + 
20G x 1.25” (0.90mm x 31.8mm) 

Protocol Number: MDS-21NRFit001 
 
CONFIDENTIAL 
Version: 2.0 
Date: 10JAN2023 
Page 54 of 56 
400229 
BD Whitacre Spinal NRFit™ Needle with introducer set 
25G × 4.06" (0.50 × 103.2 mm) + 
20G x 1.25” (0.90mm x 31.8mm) 
400230 
BD Whitacre Spinal NRFit™ Needle with introducer set 
27G × 4.06" (0.40 × 103.2 mm) + 
22G x 1.25” (0.70mm x 31.8mm) 
400224 
BD Quincke Spinal NRFit™ Needle with introducer set 
25G × 3.50ʺ (0.50 × 88.9 mm) + 
20G x 1.25” (0.90 × 31.8 mm) 
400225 
BD Quincke Spinal NRFit™ Needle with introducer set 
26G × 3.50ʺ (0.45 × 88.9 mm) + 
20G x 1.25” (0.90 × 31.8 mm) 
400226 
BD Quincke Spinal NRFit™ Needle with introducer set 
27G × 3.50ʺ (0.40 × 88.9 mm) + 
22G x 1.25” (0.70 × 31.8 mm) 
400050 
BD Syringe NRFit™ Lok 
3mL 
400172 
BD Syringe NRFit™ Slip 
3mL 
400173 
BD Syringe NRFit™ Lok 
5mL 
400051 
BD Syringe NRFit™ Slip 
5mL 
400174 
BD Syringe NRFit™ Lok 
10mL 
400175 
BD Syringe NRFit™ Slip 
10mL 
400182 
BD Syringe NRFit™ Lok 
20mL 
400183 
BD Syringe NRFit™ Lok 
50mL 
Ancillary devices 
400066 
BD Blunt Filter NRFit™ Needle 
18G x 1 ½ (1.2 mm x 40 mm) 
400067 
BD Blunt Fill NRFit™ Needle 
18G x 1 ½ (1.2 mm x 40 mm) 

Protocol Number: MDS-21NRFit001 
 
CONFIDENTIAL 
Version: 2.0 
Date: 10JAN2023 
Page 55 of 56 
16.2 ASA physical status (PS) classification - Current Definitions and ASA-Approved Examples [54]  
ASA PS 
Classification 
Definition 
Adult examples, including, but not 
limited to: 
Pediatric examples, including but not 
limited to: 
Obstetric examples, 
including but not limited to: 
ASA I 
A normal 
healthy patient 
Healthy, non-smoking, no or minimal 
alcohol use 
Healthy (no acute or chronic disease), 
normal BMI percentile for age 
 
ASA II 
A patient with 
mild systemic 
disease 
Mild diseases only without substantive 
functional limitations. Current smoker, 
social alcohol drinker, pregnancy, obesity 
(30<BMI<40), well-controlled DM/HTN, 
mild lung disease. 
Asymptomatic congenital cardiac 
disease, well controlled dysrhythmias, 
asthma without exacerbation, well 
controlled epilepsy, non-insulin 
dependent diabetes mellitus, abnormal 
BMI percentile for age, mild/moderate 
OSA, oncologic state in remission, 
autism with mild limitations. 
Normal pregnancy*, well 
controlled gestational HTN, 
controlled preeclampsia 
without severe features, diet-
controlled gestational DM. 
ASA III 
A patient with 
severe systemic 
disease 
Substantive functional limitations; One or 
more moderate to severe diseases. Poorly 
controlled DM or HTN, COPD, morbid 
obesity (BMI ≥40), active hepatitis, 
alcohol dependence or abuse, implanted 
pacemaker, moderate reduction of 
ejection fraction, ESRD undergoing 
regularly scheduled dialysis, history (>3 
months) of MI, CVA, TIA, or 
CAD/stents. 
Uncorrected stable congenital cardiac 
abnormality, asthma with exacerbation, 
poorly controlled epilepsy, insulin 
dependent diabetes mellitus, morbid 
obesity, malnutrition, severe OSA, 
oncologic state, renal failure, muscular 
dystrophy, cystic fibrosis, history of 
organ transplantation, brain/spinal cord 
malformation, symptomatic 
hydrocephalus, premature infant PCA 
<60 weeks, autism with severe 
limitations, metabolic disease, difficult 
airway, long term parenteral nutrition. 
Full term infants <6 weeks of age. 
Preeclampsia with severe 
features, gestational DM with 
complications or high insulin 
requirements, a thrombophilic 
disease requiring 
anticoagulation. 

Protocol Number: MDS-21NRFit001 
 
CONFIDENTIAL 
Version: 2.0 
Date: 10JAN2023 
Page 56 of 56 
ASA PS 
Classification 
Definition 
Adult examples, including, but not 
limited to: 
Pediatric examples, including but not 
limited to: 
Obstetric examples, 
including but not limited to: 
ASA IV 
A patient with 
severe systemic 
disease that is a 
constant threat 
to life 
Recent (<3 months) MI, CVA, TIA or 
CAD/stents, ongoing cardiac ischemia or 
severe valve dysfunction, severe reduction 
of ejection fraction, shock, sepsis, DIC, 
ARD or ESRD not undergoing regularly 
scheduled dialysis. 
Symptomatic congenital cardiac 
abnormality, congestive heart failure, 
active sequelae of prematurity, acute 
hypoxic-ischemic encephalopathy, 
shock, sepsis, disseminated intravascular 
coagulation, automatic implantable 
cardioverter-defibrillator, ventilator 
dependence, endocrinopathy, severe 
trauma, severe respiratory distress, 
advanced oncologic state. 
Preeclampsia with severe 
features complicated by 
HELLP or other adverse event, 
peripartum cardiomyopathy 
with EF <40, 
uncorrected/decompensated 
heart disease, acquired or 
congenital. 
ASA V 
A moribund 
patient who is 
not expected to 
survive without 
the operation 
Ruptured abdominal/thoracic aneurysm, 
massive trauma, intracranial bleed with 
mass effect, ischemic bowel in the face of 
significant cardiac pathology or multiple 
organ/system dysfunction. 
Massive trauma, intracranial 
hemorrhage with mass effect, patient 
requiring ECMO, respiratory failure or 
arrest, malignant hypertension, 
decompensated congestive heart failure, 
hepatic encephalopathy, ischemic bowel 
or multiple organ/system dysfunction. 
Uterine rupture. 
ASA VI 
A declared 
brain-dead 
patient whose 
organs are being 
removed for 
donor purposes 
 
 
 
* Although pregnancy is not a disease, the parturient’ s physiologic state is significantly altered from when the woman is not pregnant, hence the assignment of 
ASA 2 for a woman with uncomplicated pregnancy. 
The addition of “E” denotes Emergency surgery: (An emergency is defined as existing when delay in treatment of the patient would lead to a significant increase 
in the threat to life or body part). 

Signature Page for VV-TMF-258058 v1.0
Signature Page for VV-TMF-258058 v1.0
Reason for signing: Finalize
Name: Gloria Viti
Role: Clinical Project Management
Date of signature: 10-Jan-2023 13:46:28 GMT+0000
Reason for signing: Finalize
Name: Shuangshuang Fu
Role: Statistics and Clinical Data
Date of signature: 10-Jan-2023 14:33:08 GMT+0000
Reason for signing: Finalize
Name: John Roberts
Role: Regulatory
Date of signature: 12-Jan-2023 14:31:28 GMT+0000
Reason for signing: Finalize
Name: Edward Maratea
Role: Global Medical Affairs
Date of signature: 12-Jan-2023 15:57:30 GMT+0000
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