A Prospective, Multi-center, Randomized, Open Label, Controlled Trial of BD Pre-filled Flush Syringes
Phase: NA
Conditions: Effectiveness and Safety of Pre-filled Flush Syringe
Sponsor: Becton, Dickinson and Company

Device Name: Pre-filled Flush Syringes 
Protocol No.: MDS-21FLUSHCN01/NCT04719377 
Version No. / Version Date: V1.0/May 26, 2022 
 
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Clinical Trial Protocol for Medical Device 
 
Protocol No.: MDS-21FLUSHCN01 
 
A prospective, Multi-center, Randomized, Open-label, 
Parallel-controlled Clinical Study of Pre-filled Flush Syringes 
 
 
 
Name of the investigational medical device: Pre-filled Flush Syringes 
Model and Specification: BD 10 mL PosiFlush Pre-filled Flush Syringes 
Class III medical device that requires clinical trial approval Yes□ 
No 
Protocol version No. and date: V1.0/ May 26, 2022 
Clinical trial leading institution: Beijing Hospital 
Principal investigator: Sun Chao 
Sponsor: BD Medical Technology (Jiangsu) Co., Ltd. 
 
 
 
Statement of Confidentiality 
The ownership of all information contained in this protocol belongs to BD Medical Technology 
(Jiangsu) Co., Ltd., and can only made available for review by investigators, co-investigators, 
ethics committees, and regulatory authority and other relevant medical institutions. Without the 
written approval of BD Medical Technology (Jiangsu) Co., Ltd., it is strictly prohibited to 
disclose any information to any third party unrelated to the investigation, except for necessary 
explanation when signing the informed consent form with the potential participants of the 
investigation. 
 

Device Name: Pre-filled Flush Syringes 
Protocol No.: MDS-21FLUSHCN01/NCT04719377 
Version No. / Version Date: V1.0/May 26, 2022 
 
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Study Protocol Version Update Record 
Protocol/Amendment 
No. 
Original version No. / 
Version date 
Description of changes
Reasons for revision 
 
 
 
 
 
 
 
 
 
 
 
 

Device Name: Pre-filled Flush Syringes 
Protocol No.: MDS-21FLUSHCN01/NCT04719377 
Version No. / Version Date: V1.0/May 26, 2022 
 
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Table of Contents 
 
Table of Contents ............................................................................................................................ 3 
List of Abbreviations ....................................................................................................................... 6 
Synopsis .......................................................................................................................................... 7 
1. Information of Sponsor .......................................................................................................... 12 
1.1 Name of sponsor .................................................................................................................. 12 
1.2 Address of sponsor .............................................................................................................. 12 
1.3 Contact information of sponsor ........................................................................................... 12 
2. Information of Clinical Trial Institutions and Principal Investigators ................................... 12 
3. Background of the Clinical Trial ............................................................................................ 12 
3.1 R&D background ................................................................................................................. 12 
3.2 Basic information of product ............................................................................................... 13 
3.2.1 Structure and composition ............................................................................................. 13 
3.2.2 Principle of work and action ......................................................................................... 13 
3.2.3 Characteristics of the product ........................................................................................ 13 
3.3 Scope of application and related information ...................................................................... 13 
3.3.1 Indications ..................................................................................................................... 13 
3.3.2 Intended population ....................................................................................................... 13 
3.3.3 Site used ........................................................................................................................ 13 
3.3.4 Contact mode and duration of contact with human body .............................................. 14 
3.3.5 Severity and stage of the disease ................................................................................... 14 
3.3.6 Conditions of use ........................................................................................................... 14 
3.3.7 Repeated use .................................................................................................................. 14 
3.3.8 Use method .................................................................................................................... 14 
3.3.9 Contraindications .......................................................................................................... 14 
3.3.10 Cautions ....................................................................................................................... 14 
4. Trial Objective ........................................................................................................................ 15 
5. Trial Design ............................................................................................................................ 15 
5.1 Overall design and determination basis ............................................................................... 15 
5.2 Selection of subjects ............................................................................................................ 15 
5.2.1 Inclusion criteria ............................................................................................................ 15 
5.2.2 Exclusion criteria ........................................................................................................... 16 
5.2.3 Criteria and procedures of subject withdrawal .............................................................. 16 
5.2.4 Suspension / Termination criteria of study ................................................................... 16 
5.3 Evaluation method ............................................................................................................... 17 
5.3.1 Evaluation of effectiveness ........................................................................................... 17 
5.3.2 Safety evaluation ........................................................................................................... 18 
5.3.3 Other evaluations ........................................................................................................... 18 
5.4 Investigational medical device and control medical device ................................................ 18 
5.5 Trail procedures ................................................................................................................... 20 
5.51 Trial flow chart ............................................................................................................... 20 
5.5.2 Implementation of the trial ............................................................................................ 20 
5.6 Device operation specifications ........................................................................................... 22 
5.6.1 Study device management ............................................................................................. 22 

Device Name: Pre-filled Flush Syringes 
Protocol No.: MDS-21FLUSHCN01/NCT04719377 
Version No. / Version Date: V1.0/May 26, 2022 
 
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5.6.2 Recycling of study devices ............................................................................................ 22 
5.7 Combined treatment (medication) specifications ................................................................ 22 
5.8 Measures to control bias ...................................................................................................... 22 
6. Statistical Considerations ....................................................................................................... 23 
6.1 Estimation of sample size .................................................................................................... 23 
6.2 Analysis data sets ................................................................................................................. 23 
6.3 Subject exclusion criteria ..................................................................................................... 24 
6.4 Statistical methods ............................................................................................................... 24 
6.5 Subject number, flush syringe treatment assignment or randomization .............................. 25 
6.5.1 Subject number .............................................................................................................. 25 
6.5.2 Flush syringe treatment assignment or randomization .................................................. 25 
6.6 Handling of missing values and outliers .............................................................................. 25 
7. Monitoring Plan ...................................................................................................................... 25 
8. Data Management .................................................................................................................. 26 
8.1 Original data ........................................................................................................................ 26 
8.3 Design of eCRF ................................................................................................................... 26 
8.4 eCRF filling ......................................................................................................................... 26 
8.5 Data verification .................................................................................................................. 26 
8.6 Data quality assurance ......................................................................................................... 27 
8.7 Medical coding .................................................................................................................... 27 
8.8 Blind review ......................................................................................................................... 27 
8.9 Database locking .................................................................................................................. 27 
8.10 Submission and filing of data management documents .................................................... 27 
9. Risk Benefit Analysis ............................................................................................................. 27 
9.1 Benefit analysis .................................................................................................................... 27 
9.2 Risk analysis ........................................................................................................................ 27 
10. 
Quality Control of Clinical Trial ........................................................................................ 27 
10.1 Quality control of site ........................................................................................................ 27 
10.2 Monitoring ......................................................................................................................... 28 
11. 
Ethical Issues and Informed Consent of Clinical Trial ....................................................... 28 
11.1 Ethical considerations ........................................................................................................ 28 
11.2 Informed consent process .................................................................................................. 29 
12. 
Regulations on Reporting of Adverse Events ..................................................................... 29 
12.1 Definition and reporting requirements of adverse events .................................................. 29 
12.1.1 Definition of adverse event ......................................................................................... 29 
12.1.2 Classification of adverse event .................................................................................... 29 
12.1.3 Correlation of adverse event with devices .................................................................. 29 
12.1.4 Observation and recording of adverse events ............................................................. 30 
12.1.5 Outcome of adverse events ......................................................................................... 30 
12.1.6 Possible adverse events and their prevention and treatment ....................................... 30 
12.2 Device defects and reporting .......................................................................................... 30 
12.3 Definition of serious adverse events .................................................................................. 31 
12.4 Reporting procedures, contact information ....................................................................... 31 
13. 
Deviation from Clinical Trial Protocol and Regulations for Clinical Trial Protocol 
Revision ......................................................................................................................................... 32 
13.1 Definition of deviation ....................................................................................................... 32 

Device Name: Pre-filled Flush Syringes 
Protocol No.: MDS-21FLUSHCN01/NCT04719377 
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13.2 Measures to control deviations .......................................................................................... 33 
13.2.1 Sponsor ........................................................................................................................ 33 
13.2.2 Investigator .................................................................................................................. 33 
13.2.3 Subjects ....................................................................................................................... 33 
13.2.4 Protocol deviation reporting ........................................................................................ 33 
13.3 The provisions of the clinical trial protocol amendments.................................................. 33 
14. 
Direct Access to Source Data and Documents ................................................................... 34 
Source data refers to the original records of clinical findings, observations and other activities in 
clinical trials and all the information in their approved copies, which can be used for clinical trial 
reconstruction and evaluation. ....................................................................................................... 34 
15. 
Contents to be Covered in the Clinical Trial Report .......................................................... 34 
16. 
Confidentiality Principle ..................................................................................................... 34 
17. 
Responsibilities of All Parties ............................................................................................ 35 
17.1 Responsibilities of sponsor ................................................................................................ 35 
17.2 Responsibilities of clinical trial institutions of medical device ......................................... 36 
17.3 Responsibilities of investigators ........................................................................................ 37 
18. 
Other Contents Required to be Described .......................................................................... 38 
18.1 Basic document management ............................................................................................ 38 
18.2 Finance and insurance ........................................................................................................ 38 
Investigator’s Statement ................................................................................................................ 39 

Device Name: Pre-filled Flush Syringes 
Protocol No.: MDS-21FLUSHCN01/NCT04719377 
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List of Abbreviations 
Abbreviations 
Definition 
AE 
Adverse Event 
CRC 
Clinical Research Coordinator 
CRO 
Contract Research Organization 
D 
Day 
DMP 
Data Management Plan 
eCRF 
Electronic Case Report Form 
EDC 
Electronic Data Collection 
FAS 
Full Analysis Set 
GCP 
Good Clinical Practice (Medical Device) 
ICF 
Informed Consent Form 
MedDRA 
Medical Dictionary for Regulatory Activities 
mL 
Milliliter 
NMPA 
National Medical Products Administration 
PASS 
Power Analysis and Sample Size (Statistics Software) 
PPS 
Per Protocol Set 
PT 
Preferred term 
SAE 
Serious Adverse Event 
SAS 
Statistical Analysis System (Statistics Software) 
SOC 
System Organ Class 
SS 
Safety Set 
°C 
Celsius 

Device Name: Pre-filled Flush Syringes 
Protocol No.: MDS-21FLUSHCN01/NCT04719377 
Version No. / Version Date: V1.0/May 26, 2022 
 
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Synopsis 
Study Title 
A 
Prospective, 
Multi-center, 
Randomized, 
Open-label, 
Parallel-controlled Clinical Study of Pre-filled Flush Syringes 
Protocol No. 
MDS-21FLUSHCN01 
Sponsor 
BD Medical Technology (Jiangsu) Co., Ltd. 
Study Sites 
3 study sites 
Planned Study Period
April 2022 to September 2023 
Subject Population 
Subjects requiring locking and flushing the end of catheter line at the 
intervals of different drug treatment. 
Study Objective 
To compare the BD PosiFlush™ Pre-filled Flush Syringes 
(manufactured by BD, USA) with the pre-filled flush syringes 
(manufactured by BD Medical Technology (Jiangsu) Co., Ltd.) and 
evaluate the effectiveness and safety for locking and flushing the end 
of catheter line. 
Study Design 
This prospective, multi-center, randomized, open, and parallel-
controlled clinical study is intended to evaluate the effectiveness and 
safety of pre-filled flush syringes. 
After signing of informed consent form, all subjects who meet the 
inclusion criteria and do not meet the exclusion criteria are randomized 
into the investigational group or control group in a 1:1 ratio. 
This study is performed by 63 trial nurses using the study device
(investigational device and control device) to lock and flush the end of 
catheter line for all subjects, each nurse will randomly use 3 
investigational devices and 3 control devices. 
Number of subjects 
planned to be enrolled
Sample size calculation assumptions: 
 
Overall performance success rate in the investigational device 
group is 98% 
 
Overall performance success rate in the control device group is 
98% 
 
Non-inferiority margin is 5% 
 
Allocation ratio of 1:1 
 
Type I error rate is 0.025 one-side 
 
Power is 90% 
 
Attrition rate is 10% 
A total of 368 subjects are required. This study will be performed by 
63 study nurses using the study device, each nurse will randomly use 3 
investigational devices and 3 control devices, so a total of 378 subjects 
will be enrolled in this clinical trial. 

Device Name: Pre-filled Flush Syringes 
Protocol No.: MDS-21FLUSHCN01/NCT04719377 
Version No. / Version Date: V1.0/May 26, 2022 
 
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Efficacy Evaluation 
Primary efficacy indicator: 
The primary objective is to investigate the overall performance for 
flushing and/or locking the catheters. 
Evaluation method: 
Overall performance is assessed by a Nurse, who need to answer the 
following questions: 
1) Can air in the BD Pre-filled Flush Syringes be expelled 
successfully? 
2) Can BD Pre-filled Flush Syringes be connected to the catheter 
smoothly? 
3) Can BD Pre-filled Flush Syringes flush and /or lock the catheter 
successfully? 
4) Can BD Pre-filled Flush Syringes disconnect from the catheters 
smoothly? 
5) Any leakage observed at any part of the Flush syringe at any time 
during the usage? 
Overall performance for flushing and/or locking the catheter deemed as
"success" if: 
Question 1 to 4 answered with “YES”, and question 5 answered with 
“NO”. 
 
Secondary efficacy indicator: 
The second objective is to investigate the pushability of plunger during 
flushing and/or locking. 
Evaluation method: 
Pushability will be assessed by a Nurse who needs to score the 
following question: 
1) Is the plunger easy to push forward when flushing or locking
(pushability)? 
Score on a 5-point scale: 
 
5 points: Very easy; 
 
3 points: Easy; 
 
1 point: Difficult. 
Safety Evaluation 
The safety objective is to investigate the incidence of adverse events
and serious adverse events. 
Other Evaluation 
Device defects. 

Device Name: Pre-filled Flush Syringes 
Protocol No.: MDS-21FLUSHCN01/NCT04719377 
Version No. / Version Date: V1.0/May 26, 2022 
 
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Selection Criteria of 
Subjects 
Inclusion criteria: 
1. Age >or equal to 18, no limitation on gender; 
2. Hospitalized patients; 
3. Patients who are anticipated to need or have vascular access 
catheter devices [This may include: Peripheral Intravenous 
Catheter (PIVC), Central Venous Catheter (CVC) and Peripherally 
Inserted Central Catheter (PICC)]; 
4. Patients who are expected to require flushing the vascular access 
catheter with saline at the beginning, during, or end of infusion 
therapy, or who require to flush and/or lock vascular access 
catheters at the beginning, during, the end of drug therapy; 
5. Patients who can understand the purpose of the trial, agree to 
participate in this clinical trial and voluntarily sign the informed 
consent form. 
 
Exclusion criteria: 
1. Patient reports pregnancy or lactation (self-report); 
2. Subjects who are known to have blockage or recanalization of 
vascular access prior to this trial; 
3. Subjects who are known to have uncomfortable symptoms such as 
redness and pain, or common complication associated with 
indwelling catheter such as phlebitis and infection at the localized 
insertion site prior to this trial; 
4. Patient who has participated in a drug or medical device clinical 
trial within three months before enrollment; 
5. Any other situation that, in the opinion of the Investigator would 
make the patient considered unfit for this study. 
Withdrawal Criteria 
Subjects voluntarily withdraw from the study: 
According to the provisions of the informed consent form, subjects 
have the right to withdraw from the study at any phase of the study, or 
the subjects do not explicitly propose to withdraw from the study, but 
they no longer receive flush syringe treatments or examinations and are 
lost to follow-up, which also a category of “withdrawal” or “drop out”. 
For subjects withdrawing from the trial for any reason, it is required to 
record reasons for their withdrawal as far as possible, complete and 
report all observations in detail. 
Investigators decide to withdraw the subject from study: 
If subjects enrolled have conditions during the study that the 
investigator considers inappropriate for continuation of the study, the 
subject needs to withdraw from the study. 
Suspension / 
Termination Criteria 
of Study 
The major purpose of suspending/terminating the study is to protect the 
rights and interests of the subjects, ensure the quality of the trial and 
avoid unnecessary economic losses. Reasons for suspension/early 
termination of the study are as follows: 
1.
The sponsor may suspend/terminate the study for any scientific, 

Device Name: Pre-filled Flush Syringes 
Protocol No.: MDS-21FLUSHCN01/NCT04719377 
Version No. / Version Date: V1.0/May 26, 2022 
 
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medical or ethical reasons, but must fully consider the rights, 
safety and health of the subjects in the group; 
2. The sponsor voluntarily requests suspension/termination for other 
reasons; 
3. Drug authority, ethics committee, sponsor or investigator consider 
that there are significant safety risks; 
4. Other reasons judged by the sponsor or investigator that are 
considered inappropriate to proceed with the trial. 
The suspension arising therefrom can be a permanent “termination” or 
a temporary “suspension”. The study can be restarted after the problem 
that 
caused 
the 
suspension 
of 
the 
study 
is 
resolved. 
Suspension/termination of the study or restarting the study after 
suspension must be reported to the Ethics Committee. 
Investigational Group 
Device 
Product name: Pre-filled Flush Syringes 
Model and specification: BD 10 mL PosiFlush Pre-filled Flush 
Syringes 
Product components: The product mainly consists of barrel, plunger, 
plunger stopper, nozzle cap and 0.9% sodium chloride injection 
(conforming to ChP and USP) 
Storage conditions: 15-25°C, it can be extended to 15-30°C; do not 
freeze 
Manufacturer: BD Medical Technology (Jiangsu) Co., Ltd. 
Control Group Device Product name: BD Pre-filled Flush Syringes 
Specification/Model: BD 10mL PosiFlush Pre-filled Flush Syringes 
Product components: the product mainly consists of barrel, plunger, 
plunger stopper, nozzle cap and 0.9% sodium chloride injection 
(conforming to USP) 
Storage conditions: 20-25°C, it can be extended to 15-30°C; do not 
freeze 
Registration Certificate No.: GXZJ20163142809 
Manufacturer: Becton, Dickinson and Company 
Agent name: Becton Dickinson Medical Devices (Shanghai) Co., Ltd. 
Statistical 
Analysis 
Method 
Statistical analysis: 
This study will use SAS9.4 or above for statistical analysis. 
For quantitative variables, descriptive statistics will include number of 
subjects, mean, standard deviation, median, upper and lower quartiles, 
minimum, and maximum. 
For qualitative variables, descriptive statistics will include the number 
of subjects and percentages. 
 
Test hypotheses for the primary efficacy indicators: 
Null hypothesis H0: The overall performance success rate p1 in the 

Device Name: Pre-filled Flush Syringes 
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investigational device group is inferior to the p2 of the control device 
group (p1 ≤ p2-δ). 
Alternative hypothesis H1: The overall performance success rate p1 in
the investigational device group is non-inferior to the p2 of the control 
device group (p1 > p2-δ). 
Where δ = 5% is the non-inferiority margin, which is the range of 
differences not considered clinically significant. 
For the comparison of the main efficacy indicators between groups, the 
chi-square test or Fisher's exact test is adopted, and the confidence 
interval method is used for statistical inference to separately calculate 
the success rate of each group and the rate difference as well as 
two-sided 95% confidence interval between the two groups. If the 
lower limit of two-sided 95% CI > -5%, H0 is rejected and the overall 
performance success rate of the investigational device group can be 
considered non-inferior to the control device group. 
Descriptive analysis (quantitative or qualitative description) is 
performed for the secondary efficacy indicator, the safety evaluation 
indicator and other evaluation indicators. For categorical variables, 
summary statistics will include the number of subjects and percentage. 
For the description of adverse event, the cases of adverse events will 
also be summarized. For continuous variables, summary statistics will 
include the number of subjects, mean, standard deviation, median, 
upper and lower quartiles, minimum, and maximum. For indicators that 
require statistical inference, inter-group comparison of quantitative 
indicators is verified by t-test or Wilcoxon rank sum test based on data 
distribution characteristics; categorical indicators are verified by χ2 test 
or Fisher's exact test; ranked data is verified by Wilcoxon rank sum 
test. 
 

Device Name: Pre-filled Flush Syringes 
Protocol No.: MDS-21FLUSHCN01/NCT04719377 
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1. Information of Sponsor 
1.1 Name of sponsor 
BD Medical Technology (Jiangsu) Co., Ltd. 
1.2 Address of sponsor 
No. 888-8, Lvyuan Road, Xinjie Street, Yixing 
1.3 Contact information of sponsor 
Project leader of the clinical trial: Ma Juanjuan 
Contact number: 010-58139097 
 
2. Information of Clinical Trial Institutions and Principal Investigators 
No. 
Name of clinical trial institution 
Investigator 
Title 
Contact 
information
1 
Beijing Hospital 
Sun Chao 
Assistant 
director nurse
18601924876
2 
Beijing Friendship Hospital, Capital 
Medical University
Luo Jinkai 
Assistant 
director nurse
010-63139021
3 
Beijing Jishuitan Hospital 
Lu Xuemei 
Director nurse
010-58516783
 
3. Background of the Clinical Trial 
3.1 R&D background 
Infusion is one of the necessary measures for the diagnosis and treatment of patients in the 
hospital. Due to the needs of the disease, some patients need to use intravenous catheters or 
catheters to open up intravenous access, which facilitates rapid clinical administration of drugs 
and emergency resuscitation, while protecting patients' vascular and reducing the pain caused by 
repeated cannulation. However, when using intravenous catheters or catheters for infusion, it is 
necessary to lock the catheter with the flushing solution, usually, a manually configured heparin 
flushing solution is used. Whereas some problems are also encountered in clinical applications, 
such as blockage of intravenous catheters or catheters, and increased heparin concentration in the 
blood, resulting in short retention time of intravenous catheters or catheters, high re-cannulation 
rate, increasing patients’ pain, nursing workload and consumables, and also increasing the 
incidence of phlebitis. In clinical practice, locking of venous catheter is an important part of 
intravenous catheters infusion technology and the key to the success of intravenous catheters 
indwelling. BD PosiFlush™ Pre-filled Flush Syringes (manufactured by BD, USA), which is 
currently on the market, has a good locking effect and can effectively prevent the blockage of the 
peripheral intravenous catheter, thereby prolonging the use time of the intravenous catheter and 
reducing the pain of repeated cannulation for patients, protecting patients' vascular, reducing 
their medical costs, and also improving the efficiency of nurses. 
 

Device Name: Pre-filled Flush Syringes 
Protocol No.: MDS-21FLUSHCN01/NCT04719377 
Version No. / Version Date: V1.0/May 26, 2022 
 
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The pre-filled flush syringes developed and manufactured by BD Medical Technology (Jiangsu) 
Co., Ltd. has passed the inspection of Shandong Institute of Medical Device and Pharmaceutical 
Packaging Inspection, and the conclusion is that the product conformed to the technical 
requirements of the Pre-filled Flush Syringes. According to the Good Clinical Practice for 
Medical Devices of the National Medical Products Administration, in accordance with relevant 
national regulations and ethical requirements, as well as the characteristics and principles of 
pre-filled flush syringes, a clinical study is conducted on the safety and effectiveness of the 
pre-filled flush syringes manufactured by BD Medical Technology (Jiangsu) Co., Ltd. for 
locking and flushing the end of the catheter line, and this protocol is formulated. 
3.2 Basic information of product 
3.2.1 Structure and composition 
The product consists of barrel, plunger, plunger stopper, nozzle cap and 0.9% sodium chloride 
injection (conforming to ChP and USP). 
The pre-filled flush syringes contain sterile, pyrogen-free and preservative-free 0.9% sodium 
chloride injection, conforming to ChP and USP. The sodium chloride injection is filled in a 
plastic, single-use latex-free flush syringe. The solution is sterile. The pH of solution is 4.5-7.0. 
The osmotic pressure of the solution is 0.308 mOsm/mL (calculated). 
3.2.2 Principle of work and action 
Sodium chloride is an electrolyte replacement drug. Sodium and chloride are important 
electrolytes in the body, mainly present in extracellular fluid, and play a very important role in 
maintaining normal blood and extracellular fluid volume and osmotic pressure. 
The mechanism/mode of action of pre-filled flush syringes used to flush and/or lock vascular 
access devices is mechanical. Because the 0.9% sodium chloride injection in the pre-filled flush 
syringes can “clean out” or displace fluid from other IV catheters and fill the IV catheter as the 
locking solution. When used in conjunction with the recommended clamping technique, it 
prevents blood from entering the catheter and clotting. The 0.9% sodium chloride solution in the 
pre-filled flush syringes is used as a fluid replacement solution because of basic compatibility 
with the blood and has no intended therapeutic effect of its own (no actual drug mode of action). 
The 0.9% sodium chloride in the pre-filled flush syringes does not damage blood components. 
3.2.3 Characteristics of the product 
 
Used as a flushing/locking device for vascular access devices without the risk of 
heparin-induced thrombocytopenia (HIT); 
 
The pre-filled flush syringes eliminate the steps and time involved in manually preparing 
saline syringes, increasing the efficiency of clinical nurses and optimizing workflow; 
 
Pre-filled flush syringes can reduce the risk and/or degree of blood reflux caused by the 
syringe. 
3.3 Scope of application and related information 
Pre-filled flush syringes are intended to lock and flush the end of the catheter line at the intervals 
of different drug treatment. 
3.3.1 Indications 
Not applicable. 
3.3.2 Intended population 
Subjects requiring locking and flushing the end of catheter line at the intervals of different drug 
treatment. 
3.3.3 Site used 

Device Name: Pre-filled Flush Syringes 
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The end of the catheter line used by the subject. 
3.3.4 Contact mode and duration of contact with human body 
The pre-filled flush syringes do not contact with the human body directly, but the sterile, 
pyrogen-free and preservative-free 0.9% sodium chloride injection (conforming to ChP and USP) 
contained in it will eventually enter the human body. 
3.3.5 Severity and stage of the disease 
Not applicable. 
3.3.6 Conditions of use 
Used by clinicians and nurses. Do not use on sterile interface or in sterile environment. 
3.3.7 Repeated use 
The pre-filled flush syringes are a single-use product, not reusable. 
3.3.8 Use method 
1. Tear open package and take out the pre-filled flush syringe. 
2. Depress plunger (do not open white tip cap) with tip cap on to relieve the resistance 
between the stopper and the barrel. 
3. Use aseptic technique, and remove tip cap by twisting off. 
4. If connecting with a needleless I.V. system, please attach directly. If for traditional ports, 
please connect a needle with safety engineered feature as required by OSHA bloodborne 
Pathogens Standard. 
5. Hold the syringe upright and expel the air in the syringe. 
6. Attach the syringe to the port, valve or needleless system and flush following institution's 
policy and indwelling device manufacturer's recommendations. 
7. Discard used syringe and any unused portion of the solution according to institution 
policy. Do not reuse. 
3.3.9 Contraindications 
Not yet clear; not found yet. 
3.3.10 Cautions 
1. Do not use if the packaging is incomplete. 
2. Do not use if the pre-filled flush syringe is damaged and leaking. 
3. Do not use if the nozzle cap is installed incorrectly or detached. 
4. Do not use if any form of suspended particles is inspected visually or the solution is 
discolored, turbid, and precipitated. 
5. Do not re-sterilize. 
6. Check the expiration date on the packaging label and do not use if the product is 
expired. 
7. Do not place the pre-filled flush syringe on a sterile interface or in sterile environment. 
8. Do not reuse. Single use only. Discard any remaining parts of the unused. 
9. Do not contact the solution with medicines incompatible. Please refer to the 
compatibility literature. 
 

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4. Trial Objective 
To compare the BD PosiFlush™ Pre-filled Flush Syringes (manufactured by BD, USA) with the 
pre-filled flush syringes (manufactured by BD Medical Technology (Jiangsu) Co., Ltd.) and 
evaluate the effectiveness and safety for locking and flushing the end of catheter line. 
 
5. Trial Design 
5.1 Overall design and determination basis 
Overall design 
Selection of trial method: this trial is a prospective, multi-center, randomized, open, 
parallel-controlled clinical trial. The investigational product is the Pre-filled Flush Syringes 
(specification and model: BD 10 mL PosiFlush pre-filled flush syringes), and the control product 
is the BD Pre-filled Flush Syringes (specification and model: BD 10 mL PosiFlush pre-filled 
flush syringes), a statistical design will be performed using non-inferiority statistical 
comparisons. 
Prospective: The study method with signed informed consent form as the starting point and 
follow-up to 1 hour after the end of the catheter locking and flushing treatment. 
Randomization: A block randomization method is used and SAS9.4 or above software is adopted 
to generate the random assignment list for subjects. After confirming that the subjects meet the 
eligibility evaluation of the inclusion and exclusion criteria, the investigator or authorized 
personnel logs in to the randomization system to obtain the random number and corresponding 
group information, then the study nurses perform the trial intervention according to the random 
assignment results. 
Open: Due to the difference in the appearance between the investigational product and the 
control product (the printing on the smallest package is inconsistent), and the use of incomplete 
packaging is prohibited, the investigators and subjects cannot be blinded in the trial, so an open 
design is used for this trial. 
Parallel control: Because there are already equivalent products on the market, the design of 
parallel control is selected. The equivalent products are the BD Pre-filled Flush Syringes with 
proven efficacy and safety. 
Multi-center: Three institutions with clinical trial qualifications are selected to carry out this 
clinical trial. The subjects are enrolled in multiple sites and come from a wide range of subjects 
to avoid the bias of trial results caused by systematic errors at a single site. 
Non-inferiority test: To evaluate that the overall performance of the pre-filled flush syringes for 
flushing and/or locking the catheter is non-inferior to that of the BD Pre-filled Flush Syringes. 
After signing of informed consent form, all subjects who meet the inclusion criteria and do not 
meet the exclusion criteria are randomized into the investigational group or control group in a 
1:1 ratio. 
The end of catheter line for all subjects is flushed and/or locked by the study nurse using study 
devices (investigational device and control device) to evaluate the effectiveness and safety of 
pre-filled flush syringes. 
The study process includes three periods: screening period, treatment period with flush syringes, 
and follow-up period. The screening period is up to 3 days. Follow-up is conducted 1 hour after 
the end of the flush syringe treatment to assess safety and effectiveness. 
5.2 Selection of subjects 
5.2.1 Inclusion criteria 

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1) Age >or equal to 18, no limitation on gender; 
2) Hospitalized patients; 
3) Patients who are anticipated to need or have vascular access catheter devices [This may 
include: Peripheral Intravenous Catheter (PIVC), Central Venous Catheter (CVC) and 
Peripherally Inserted Central Catheter (PICC)]; 
4) Patients who are expected to require flushing the vascular access catheter with saline at 
the beginning, during, or end of infusion therapy, or who require flush and/or lock 
vascular access catheters at the beginning, during, the end of drug therapy; 
5) Patients who can understand the purpose of the trial, agree to participate in this clinical 
trial and voluntarily sign the informed consent form. 
5.2.2 Exclusion criteria 
1) Patient reports pregnancy or lactation (self-report); 
2) Subjects who are known to have blockage or recanalization of vascular access prior to 
this trial; 
3) Subjects who are known to have uncomfortable symptoms such as redness and pain, or 
common complication associated with indwelling catheter such as phlebitis and 
infection at the localized insertion site prior to this trial; 
4) Patient who has participated in a drug or medical device clinical trial within three 
months before enrollment; 
5) Any other situation that, in the opinion of the Investigator would make the patient 
considered unfit for this study. 
5.2.3 Criteria and procedures of subject withdrawal  
5.2.3.1 Investigator-decided withdrawal 
If subjects enrolled have conditions during the study that the investigator considers inappropriate 
for continuation of the study, the subject needs to withdraw from the study. 
5.2.3.2 Subjects voluntarily withdraw from the study 
According to the provisions of the informed consent form, subjects have the right to withdraw 
from the study at any phase of the study, or the subjects do not explicitly propose to withdraw 
from the study, but they no longer receive flush syringe treatments or examinations and are lost 
to follow-up, which is also a category of “withdrawal” or “drop-out”. 
For subjects withdrawing from the trial for any reason, it is required to record reasons for their 
withdrawal as far as possible, complete and report all observations in detail. 
5.2.3.3 Withdrawal (drop-out) handling 
Drop-out refers to any subject who has signed the informed consent form (ICF), has passed the 
screening, and is enrolled in the clinical trial randomly but withdraws from the clinical trial at 
any time for any reason is considered a drop-out case. 
For subjects who drop out of this trial, the reasons for withdrawal from the trial and the 
completed operations before drop-out shall be documented. 
If the subject withdraws from this trial due to adverse events, timely and appropriate flush 
syringe treatments and follow-up examinations shall be performed until the adverse events are 
recovered (return to normal state or to baseline state), or until the condition is stable, or until a 
reasonable explanation is available. 
5.2.4 Suspension / Termination criteria of study 
The major purpose of suspending/terminating the study is to protect the rights and interests of the 

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subjects, ensure the quality of the trial and avoid unnecessary economic losses. Reasons for 
suspension/early termination of the study are as follows: 
1. The sponsor may suspend/terminate the study for any scientific, medical or ethical 
reasons, but must fully consider the rights, safety and health of the subjects in the group; 
2. The sponsor voluntarily requests suspension/termination for other reasons; 
3. Drug authority, ethics committee, sponsor or investigator consider that there are 
significant safety risks; 
4. Other reasons judged by the sponsor or investigator that are considered inappropriate to 
proceed with the trial. 
The suspension arising therefrom can be a permanent “termination” or a temporary “suspension”. 
The study can be restarted after the problem that caused the suspension of the study is resolved. 
Suspension/termination of the study or restarting the study after suspension must be reported to 
the Ethics Committee. 
5.3 Evaluation method 
5.3.1 Evaluation of effectiveness 
5.3.1.1 Primary efficacy indicators and evaluation time 
 Overall performance of flushing and/or locking catheters 
Definition: The success rate of the prefilled flush syringes for flushing and/or locking 
the catheter. 
Observation time: Flushing and/or locking the catheter during preparation, initiation, 
implementation, termination. 
Evaluation criteria: The success rate of flushing and/or locking the catheter = (number 
of cases evaluated as "successful"/total number of cases evaluated) × 100%. 
Evaluation method: 
Overall performance is assessed by a Nurse, who need to answer the following questions: 
1) Can air in the BD Pre-filled Flush Syringes be expelled successfully? 
2) Can BD Pre-filled Flush Syringes be connected to the catheter smoothly? 
3) Can BD Pre-filled Flush Syringes flush and /or lock the catheter successfully? 
4) Can BD Pre-filled Flush Syringes disconnect from the catheters smoothly? 
5) Any leakage observed at any part of the Flush syringe at any time during the usage? 
Overall performance for flushing and/or locking the catheter is only considered as "success" if: 
Question 1 to 4 answered with “YES”, and question 5 answered with “NO”. 
Justifications of indicators selected: The effectiveness of this product is mainly reflected in 
five aspects: priming, connection, flushing and/or locking catheters, disconnection from catheters 
and leakage. 
Cautions: None. 
5.3.1.2 Secondary efficacy indicators and evaluation time  
 Easy pushability of the plunger when flushing and/or locking. 
Definition: Whether the plunger can be easily pushed forward when the pre-filled flush 
syringe is flushing and/or locking? 
Observation time: Flushing and/or locking the catheter during implementation, 

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termination. 
Evaluation criteria: The pushability of the plunger when flushing and/or locking = 
(number of cases evaluated with score ≥ 3 points/total number of cases evaluated) × 
100%. 
Evaluation method: 
Pushability will be assessed by a Nurse, who needs to score the following question: 
1) Is the plunger easy to push forward when flushing and/or locking (pushability)? 
5-point scale will be used: 
 
5 points: Very easy; 
 
3 points: Easy; 
 
1 point: Difficult. 
5.3.2 Safety evaluation 
Observation purpose: To evaluate the safety of the pre-filled flush syringe for flushing and/or 
locking the end of catheter line. 
(1) Safety 
 Adverse events and serious adverse events 
(2) Method and time selection for evaluating, recording and analyzing safety indicators 
1) Evaluation method (calculation formula) 
 
Calculate the incidence of adverse events, serious adverse events: number of subjects 
experiencing the above events/total number of subjects × 100%. 
2) Time selection 
Adverse events/serious adverse events are recorded at all times. 
3) Analytical method 
See section 6.4 for statistical analysis method. 
5.3.3 Other evaluations 
(1) Device defects 
 Device defects that occur during the trial. 
(2) Method and time selection for evaluating, recording and analyzing safety indicators 
1) Evaluation method (calculation formula) 
 
Calculate the incidence of device defects: subjects experiencing the above events/total 
number of subjects × 100%. 
2) Time selection 
Device defects are recorded at all times. 
3) Analytical method 
See section 6.4 for statistical analysis method. 
5.4 Investigational medical device and control medical device 
Investigational group device 
Product name: 
Pre-filled flush syringes 
Specification/Model: 
BD 10mL PosiFlush Pre-filled Flush Syringes 

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Registrant: 
BD Medical Technology (Jiangsu) Co., Ltd. 
Shelf life: 
3 years 
Storage conditions: 
15°C-25°C. It can be extended to 15°C-30°C; do not freeze. 
Intended use: 
Used to lock and flush the end of a catheter. It is not suitable for subcutaneous 
injection and intramuscular injection. 
Product composition: 
The product consists of barrel, plunger, plunger stopper, nozzle cap and 0.9% 
sodium chloride injection (conforming to ChP and USP). 
 
Control group device 
Product name: 
BD Pre-filled Flush Syringes 
Specification/Model: 
BD 10mL PosiFlush Pre-filled Flush Syringes 
Registrant: 
Becton, Dickinson and Company 
Agent: 
Becton Dickinson Medical Devices (Shanghai) Co., Ltd. 
Registration Certificate 
No.: 
GXZJ20163142809 
Shelf life: 
3 years 
Storage conditions: 
20°C-25°C. It can be extended to 15°C-30°C; do not freeze. 
Intended use: 
Intended to lock and flush the end of the catheter line at the intervals of different 
drug treatment. It is not suitable for subcutaneous injection and intramuscular 
injection.
Product composition: 
The product consists of barrel, plunger, plunger stopper, nozzle cap and 0.9% 
sodium chloride injection (conforming to USP). 

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5.5 Trail procedures 
5.51 Trial flow chart  
Item            Time 
Screening period 
(D-2,-1,0) 
Flush syringe 
treatment period 
(D1) 
Follow-up period 
(1h after the flush 
syringe treatment)
Sign the informed consent 
form
▲ 
 
 
Hospital admission 
diagnosis/demographic data
▲ 
 
 
Review inclusion/exclusion 
criteria
▲ 
 
 
Randomization 
▲ 
 
 
Vital signs1 
▲ 
 
 
Evaluation of effectiveness 
 
▲ 
 
Record adverse 
events/serious adverse 
events2
▲ 
▲ 
▲ 
Record combined 
medications/treatments3
▲ 
▲ 
▲ 
Device defects 
 
▲ 
 
 
Note: The screening period and the treatment period can be the same day. 
1. Vital signs: Record the recent last examination result prior to the flush syringe treatment. 
2. Record adverse events: Collect and record the adverse events in each subject during the 
period from the signing the informed consent form to the termination of follow-up. 
Investigator should follow up the adverse events, follow up the subject undergoing such 
adverse events until the adverse events are recovered (return to normal state or to baseline 
state), or until the condition is stable, or until a reasonable explanation is available. 
3. Combined medication/treatment: Collect and record the combined medication before and 
after the use of the study device during the trial (the closest one to such use, twice in total), 
and the medication and the study device shall pass through the same vascular access 
(excluding oral medication); medication/treatment for adverse events. 
5.5.2 Implementation of the trial 
Subjects will be trained for the use of Pre-filled flush syringes prior to enrollment. Investigators 
using the device (Investigational group device and/or Control group device) shall be specialized 
in intravenous infusion therapy for at least 2 years; maintain peripheral or central vascular access 
more than 10 times per month for the last 6 months; complete the product use of pre-filled flush 
syringes as required and complete assessment after training. 
The informed consent form shall be signed by each subject before screening. Refer to the "trial 
flow chart” for the specific trial process. 
This clinical trial is divided into three phases: screening period, flush syringe treatment period 
and follow-up period:

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The first phase is the screening period with a maximum of 3 days. The screening period and the 
flush syringe treatment period can be the same day. During the screening period, a visit will be 
set up to review the inclusion/exclusion criteria of the subjects to ensure that the subjects meet 
the enrollment conditions. All selected subjects shall be randomly assigned to the investigational 
group or the control group in a ratio of 1:1. 
The second phase is the flush syringe treatment period. During this period, a fixed visit is set up 
on the day of the flush syringe treatment to complete the operation of the treatment and record 
the effectiveness and safety as per the protocol. 
The third phase is the follow-up period. A follow-up shall be performed at 1 hour after the flush 
syringe treatment. 
The visiting investigators shall be required to observe, treat and record the subjects in each phase 
according to the flow chart. 
Screening period (D-2,-1,0) 
1) Sign the informed consent form (Note: Relevant screening examinations shall not be 
performed before the written informed consent form is obtained); 
2) Demographic data collection: date of birth, gender, ethnicity, etc.; 
3) Hospital admission diagnosis; 
4) Register the subject screening number of the selected patients, and review the subject 
inclusion and exclusion criteria; 
5) Randomization; 
6) Vital signs: Respiration, blood pressure (systolic pressure, diastolic pressure), pulse, body 
temperature; 
7) Record adverse events and serious adverse events; 
8) Record combined medications/treatments. 
 
Flush syringe treatment period (D1) 
Flush syringe treatment period indicates the use and operation of pre-filled catheter flush 
syringes. 
1) The operation shall be performed to flush and/or lock the end of the catheter line: 
The procedure shall be performed to flush and/or lock the end of the catheter line by the 
study nurse. Refer to section 3.3.8 Usage for the specific operation method. 
Record the time to start and end the flush syringe treatment. 
Before the priming preparation, if device defects and other problems are found, each 
subject can change a new study device; if such problems are found after the priming 
preparation, each subject can only use the current one without changing the device. 
2) Evaluation of effectiveness: 
The use of the pre-filled flushing syringe shall be evaluated by the study nurse after 
flushing and/or locking the end of the catheter line. Refer to section 5.3.1 Evaluation of 
effectiveness for the specific evaluation method. 
3) Record adverse events (AE/SAE); 
4) Record combined medications/treatments; 
5) Record device defects. 
Follow-up 

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Follow-up is performed at 1 hour after the flush syringe treatment. 
1) Record adverse events (AE/SAE); 
2) Record combined medications/treatments. 
5.6 Device operation specifications 
5.6.1 Study device management 
1) The relevant training shall be received by the users before using the device. And the users 
shall be familiar with the use of the device with the ability to identify the abnormality of 
the device. The users shall avoid results errors caused by human factors. 
2) Inspect visually whether the package of the device is complete or damaged before using. 
5.6.2 Recycling of study devices 
The sponsor is responsible for recycling the study devices after the termination or at the end of 
the trial. The “Device Recycling Form” shall be signed by both parties, and all related materials 
shall be counted at the end of the trial. For specific device recycling matters, please contact the 
project manager of this clinical trial. 
Conduct device recycling as follows and count the quantities: 
1. Used study products 
Study products that are not invalid, damaged, defective or involved in adverse events, and 
those involved in adverse events but determined as definitely unrelated to adverse events 
according to the judgment of the investigator, can be destroyed according to the 
regulations of the study site after use, without any need for recycling. Destruction of 
study products shall be recorded. 
2. Unused study products 
After the termination of the trial, the sponsor will collect all unused investigational and 
control medical devices. At the end of the study, all related materials must be counted. 
3. 
Defective devices and devices related to adverse events: 
In the following cases, the device shall be recycled and the relevant form for recycling 
devices shall be filled in: 
 Damaged or defective products; 
 Products that fail or malfunction during the study; 
 Products that cannot be used due to improper storage conditions; 
 Products with incorrect information on the packaging, such as incorrect expiration 
date; 
 Products related to adverse events, regardless of whether they are damaged, defective 
or faulty. 
In addition, the paper outer packaging of the study device shall be not recycled. 
5.7 Combined treatment (medication) specifications 
Collect and record the combined medication before and after the use of the study device during 
the trial (the closest one to such use, twice in total), and the medication and the study device 
shall pass through the same vascular access (excluding oral medication); medication/treatment 
for adverse events. 
5.8 Measures to control bias 
1) The sponsor shall provide relevant training for the investigator prior to the initiation of 
the study, so as to ensure that the investigators fully understand the study process and 

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are proficient in using the study product. 
2) The operation shall be performed in strict accordance with the operation methods and 
procedures stipulated in the study protocol during the study process. And the quality 
control and supervision shall be conducted properly by the clinical research associate 
(CRA) to ensure that the investigators operate and implement in strict accordance with 
the study protocol. The above measures shall be implemented throughout the 
implementation phase of the study to reduce mistakes or operational errors. 
3) The subjects shall be screened in strict accordance with the inclusion and exclusion 
criteria of the trial protocol to reduce selectivity bias for subjects. 
4) The clinical study shall be performed by selecting trials or controls in a random way to 
reduce trial bias caused by sampling error. 
5) The data shall be recorded properly during the process of the study. When the study is 
completed, the data shall be retained and organized properly. When any data problem is 
found, the data manager shall confirm the data through the data challenge form to avoid 
the data error. 
6. Statistical Considerations 
6.1 Estimation of sample size 
A total of 378 subjects are proposed to be enrolled in this clinical trial. This study is a 
non-inferiority design with parallel control. The equivalent products already available on the 
market (BD Pre-filled Flush Syringes) are selected as the control group device. The study intends 
to investigate that the overall performance of the investigational device group device for flushing 
and/or locking the catheter is non-inferior to that of the control group device. According to 
previous clinical experience, the overall performance success rate of equivalent devices for 
flushing and/or locking catheters is about 98%. Hence, it is assumed that the treatment 
completion rate of the investigational device group is consistent with that of the equivalent 
device. This study adopts a non-inferiority design, with α=0.025 (one-sided), β=0.1 (power of 
test of 90%), and the non-inferiority margin of 5%. The subjects in the investigational device 
group and the control group are allocated in an equal ratio of 1:1. The sample size shall be 
calculated to each enroll 165 subjects into the investigational device group and the control group 
by using the PASS software. However, 368 subjects shall be included to participate in this 
clinical study considering factors such as drop-out of subjects (drop-out rate of 10%) during the 
trial and other factors. 
This study will be performed by 63 authorized nurses who participate in using the study device, 
each nurse will randomly use 3 investigational devices and 3 control devices, so a total of 378 
subjects will be proposed to be enrolled in this clinical trial. 
Minimum and maximum number of subjects and reasons for each clinical trial institution 
This trial will be conducted simultaneously in multiple clinical trial institutions to enroll subjects. 
In principle, the subjects enrolled at each site will be distributed as evenly as possible to ensure 
adequate site representation. However, given the feasibility and enrollment progress, the number 
of subjects enrolled at each site will be properly adjusted according to the actual situation, so as 
to ensure the relative balance of the enrollment size of each site, and the final enrollment size of 
a particular site shall not exceed 50% of the total number of cases, and at least not less than half 
of the number of cases borne by the average distribution. 
6.2 Analysis data sets 
Full analysis set (FAS): a data set consisting of all randomized subjects according to the basic 
principle of intention-to-treat analysis. 
Per protocol set (PPS): refers to the subjects in the FAS who are of no serious violation against 

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the trial protocol, good compliance, and no missing primary efficacy indicators. 
Safety set (SS): refers to the subjects who receive at least one study device treatment and at least 
one safety evaluation. 
Efficacy analysis is to be performed based on the full analysis set and per protocol set. PPS will 
be used as the primary population for analyzing primary efficacy indicators in this study; FAS 
will be used as the population for analyzing the baseline data of this study, as well as for efficacy 
evaluation. SS will be used as the primary population for the safety analysis in this study. 
6.3 Subject exclusion criteria 
Investigators, sponsors, data management and statistical analysis units comprehensively judge 
whether to exclude patients based on factors such as the degree to which subjects completed the 
trial and the reasons for withdrawal. FAS subjects shall be excluded from PPS if they meet one 
of the following:  
(1) Subjects who do not meet the inclusion criteria or meet any of the exclusion criteria are 
mistakenly included in the trial; 
(2) Subjects with missing primary efficacy indicators; 
(3) Subjects who are in major violation of the trial protocol and with poor compliance; 
(4) Subjects with other special reasons. 
Specific subject exclusion will be determined through discussion between the investigator, 
sponsor, data administrator and statistician at the data review meeting. 
6.4 Statistical methods 
This study will use SAS9.4 or above for statistical analysis. Statistical description shall be 
performed for all data, including baseline data, all effectiveness indicators, and all safety 
indicators, etc. 
For quantitative variables, descriptive statistics will include number of subjects, mean, standard 
deviation, median, upper and lower quartiles, minimum, and maximum. 
For qualitative variables, descriptive statistics will include the number of subjects and 
percentages. 
Statistical test for the primary efficacy indicators is carried out with two-sided α=0.05. When P is 
less than 0.05, the inter-group difference is considered statistically significant. 
Test hypotheses for the primary efficacy indicators: 
Null hypothesis H0: The overall performance success rate p1 in the investigational device group is 
inferior to the p2 of the control device group (p1 ≤ p2-δ). 
Alternative hypothesis H1: The overall performance success rate p1 in the investigational device 
group is non-inferior to the p2 of the control device group (p1 > p2-δ). 
Where δ = 5% is the non-inferiority margin, which is the range of differences not considered 
clinically significant. 
For the comparison of the main efficacy indicators between groups, the chi-square test or Fisher's 
exact test is adopted, and the confidence interval method is used for statistical inference to 
separately calculate the success rate of each group and the rate difference as well as two-sided 
95% confidence interval between the two groups. If the lower limit of two-sided 95% CI > -5%, 
H0 is rejected and the overall performance success rate of the investigational device group can be 
considered non-inferior to the control device group. 
Descriptive analysis (quantitative or qualitative description) is performed for the secondary 
efficacy indicator, the safety evaluation indicators and other evaluation indicators. For 
categorical variables, summary statistics will include the number of subjects and percentage. For 

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the description of adverse event, the cases of adverse events will also be summarized. For 
continuous variables, summary statistics will include the number of subjects, mean, standard 
deviation, median, upper and lower quartiles, minimum, and maximum. For indicators that 
require statistical inference, inter-group comparison of quantitative indicators is verified by t-test 
or Wilcoxon rank sum test based on data distribution characteristics; categorical indicators are 
verified by χ2 test or Fisher's exact test; ranked data is verified by Wilcoxon rank sum test. 
6.5 Subject number, flush syringe treatment assignment or randomization 
6.5.1 Subject number 
Each subject will receive a unique screening number, and once a subject has been assigned a 
screening number, this screening number cannot be assigned to other subjects. This screening 
number must be recorded on the screening form at each site. Screening numbers will be assigned 
in the order in which subjects are screened. The screening results shall be recorded in a screening 
form. Data on the screened subjects, including reasons for screening failure, shall also be input 
into the electronic case report form (eCRF). 
6.5.2 Flush syringe treatment assignment or randomization 
The random number of the subject will be provided by the statistical analysis unit commissioned 
by the sponsor, and the random assignment table of the subject will be generated using SAS9.4 
or above. Given the number of seeds and block length, subjects are randomly assigned to the trial 
and control groups in a 1:1 ratio through a block randomization method. 
The random number of the subjects is a 3-digit "site number". If the serial number is less than 3 
digits, "0" is added to the front so as to make up 3 digits.  
Subject randomization is completed by an Interactive Web Response System (IWRS). 
Systematic randomization work will be carried out by the investigator or relevant personnel 
authorized by the investigator. After the successful screening of subjects in each center, the 
investigators or other authorized personnel log in to the randomization system to obtain the 
random number and corresponding group information, then study nurses perform the trial 
intervention according to the random assignment results. 
6.6 Handling of missing values and outliers 
All missing, unused or incorrect data (including midway withdrawal and exit) and unreasonable 
data will be discussed and finalized by the investigator, sponsor and biostatistician. 
Unless otherwise stipulated, missing values of all analysis indicators will not be filled. 
7. Monitoring Plan 
According to the requirements in Good Clinical Practice for Medical Devices, the sponsor shall 
undertake monitoring responsibilities for the medical device clinical trial, formulate standard 
operating procedures for monitoring and select monitors who conform to the requirements to 
fulfill the responsibilities of monitoring: 
The monitor number and monitoring frequency shall be commensurate with the complexity of 
the trial and the number of clinical trial institutions participating in this trial.  
The monitors shall be properly trained, be familiar with GCP and relevant laws and regulations, 
have relevant professional background expertise, be familiar with relevant research materials of 
investigational medical devices and clinical information of similar products, clinical trial 
protocol and related documents, and be able to effectively perform monitoring responsibilities. 
The monitors shall abide by the standard operating procedures for monitoring formulated by the 
sponsor, and urge the clinical trial of medical devices to be implemented in accordance with the 
clinical trial protocol. The aspects to be monitored include the compliance with clinical trial 
protocol, GCP and relevant laws and regulations by the clinical trial institutions and the 

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investigators during the conduct of the clinical trial, the signing of informed consent by subjects, 
screening, follow-up, rights and security protection, management and use of investigational 
device and control device, management and use of biological samples, handling of adverse 
events and device defects, reporting of safety-related information, data records of clinical trial 
and completion of case report forms etc. The monitors shall report to the sponsor in writing after 
each monitoring which shall include the name of the monitor, monitoring date, monitoring time, 
site monitored, aspects monitored, name of investigator, project completion information, issues 
identified, conclusion and the corrective measures taken for the mistakes and omissions etc. 
8. Data Management 
Data managers shall prepare a data management plan (DMP) according to project requirements 
and carry out various specific data management work according to the DMP to ensure the 
authenticity, integrity and traceability of clinical trial data. 
8.1 Original data 
The original data can confirm the real existence of the subject and the integrity and authenticity 
of the data. All data recorded in the Electronic Data Capture System (EDC) is derived from the 
original data and shall therefore be consistent with the original data. If the data in the EDC is 
inconsistent with the original data, it shall be modified according to the original data, or be 
provided with a reasonable explanation. The original data is stored in each trial site. Original 
data includes but are not limited to the following documents: 
 
Medical records; 
 
Informed consent form of the subjects; 
 
Related forms or documents that record information on efficacy and safety. 
8.2 EDC system 
This study will use the EDC system to collect data. It has been fully verified and can save the 
audit trail and manage accounts and permissions well. 
The EDC system will automatically save the audit trail of the data, including the time of data 
entry and change, the operator, the reason for the change, the data value before the change, the 
data value after the change, etc., to ensure the traceability of the data. 
System administrators separately create accounts for different roles, grant different permissions 
for them, and strictly manage and control account application and cancellation. 
8.3 Design of eCRF 
Data managers design case report forms according to the study protocol and with reference to the 
Clinical Data Acquisition Standards Harmonization (CDASH). Database designers build eCRF 
in EDC and set up logical verification procedures; data managers carry out testing of the 
database and can only be published online unless the testing is passed. 
8.4 eCRF filling 
The eCRF is filled out by the investigator or an authorized clinical study coordinator (CRC) 
based on the source documents (original medical records, examination reports, etc.) and the 
investigator is responsible for timely and accurate entry of the study data into the EDC. The 
monitor dispatched by the sponsor shall confirm that all data records and reports are correct and 
complete, and that the data in all EDCs is consistent with the original data. 
8.5 Data verification 
After the eCRF is filled out, the data will be verified by means of computer program verification 
and manual verification according to the data management plan. The suspicious data points 
found in the verification shall be managed in the form of query, and the investigator or CRC 
shall promptly reply to the query. 

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8.6 Data quality assurance 
This study will employ quality control and data verification processes to ensure the reliability 
and accuracy of the clinical database. The monitoring plan and data management plan will detail 
the data entry, inspection, clarification and verification processes that all relevant study staff 
shall follow to ensure compliance with Good Clinical Practice. 
8.7 Medical coding 
The medical coders will be responsible for the medical coding of this study. adverse events, 
hospital admission diagnosis, etc. Those will be coded using MedDRA 24.0 or above. The 
medical coding operation will follow the "Medical Coding Plan” in which the contents of 
medical coding entry, dictionary version, dictionary update, coding review, etc. are specified in 
detail. 
8.8 Blind review 
Not applicable. 
8.9 Database locking 
After all doubts have been resolved and the data in the database are confirmed to be complete 
and accurate, the representatives of the sponsor, principal investigators, statistical analysts, and 
data managers will jointly approve the database, and then the database manager will lock the 
database. 
8.10 Submission and filing of data management documents 
After the database is locked, the data managers will prepare a data management report according 
to the actual implementation of the project, and complete the submission and filing of paper and 
electronic documents according to the management requirements of the project document. 
9. Risk Benefit Analysis 
9.1 Benefit analysis 
Pre-filled Flush Syringes have been on the market for many years at home and abroad, and it has 
been proven that the use of Pre-filled Flush Syringes can improve the accuracy of drug 
administration, reduce the risk of drug administration and medication errors, as well as reduce 
the risk of microbial contamination to improve the safety and convenience of use. Therefore, it is 
intended that the safety performance of the trial product is reliable and can meet the requirements 
of clinical trials. 
9.2 Risk analysis 
Transient taste and/or odor disturbances may occur with the use of Pre-filled Flush Syringes. In 
the course of the trial, the effective cases may be insufficient if a significant number of subjects 
drop out from the trial, or the quality of the trial may be affected due to the non-standard 
operation of the trial personnel. 
10. Quality Control of Clinical Trial 
10.1 Quality control of site 
The clinical study protocol shall be discussed and formulated by the principal investigators who 
participate in the trial prior to the initiation of the formal trial, so as to ensure the quality of the 
trial. Relevant training will be provided for the relevant medical staff participating in this trial. 
The data collected shall be guaranteed to be accurate, consistent, complete and credible during 
the study conduct phase. All observed results and abnormal findings in clinical trials shall be 
carefully verified and recorded in a timely manner to ensure the reliability of the data. 
All laboratories of each clinical site shall establish consistent criteria of test index, standard 
operating procedures and quality control procedures. The national legal measurement unit shall 

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be adopted for each trial test item and the items in the test report must be complete (including 
date, test items, test results and normal range) and signed by the relevant personnel. Special 
examination items shall be specially designated to the personnel who is responsible for testing. 
The relevant training shall be received by the users of measuring equipment before using the 
equipment. They shall be familiar with the use of equipment to avoid measurement errors in trial 
data caused by human factors. Meanwhile, the proper maintenance of the equipment shall be 
carried out on a regular basis to ensure the measuring accuracy of clinical trial data and the 
normal operation of the equipment. All equipment used for trial data measurement shall acquire 
relevant access documents or certificates on sales in Chinese market, and its shelf life shall be 
within the warranty period and the equipment shall be in good condition. Calibration shall be 
performed before use to ensure measuring accuracy. 
10.2 Monitoring 
Sponsors shall dispatch trained monitors for regular and irregular monitoring in the course of the 
trial. The monitor is responsible for monitoring whether the clinical facilities of the study sites 
meet the requirements and whether the trial personnel follow the trial protocol and accurately 
record the trial results. The monitor must also review the eCRF with original documents and 
inform the investigator of any omissions or errors during each monitoring session, and must 
review the use record of the device to ensure compliance with the requirements of the protocol. 
The monitor shall confirm that all AEs are recorded, and SAEs are reported and recorded within 
the specified time. The monitor shall submit the written report to the sponsor in a timely manner 
after each monitoring. 
Medical monitoring is completed by medical monitors and will be carried out throughout the 
entire process of the trial, including but not limited to review of enrollment qualifications, 
protocol violations, regular clinical trial data, and data during follow-up, etc. 
According to the requirements of the GCP for medical devices, the study sites must also be 
audited by auditors appointed by the sponsor. The auditors will conduct systematic and 
independent inspection of activities and documents related to the clinical trial of medical device 
to determine that whether the implementation of such activities, recording, analysis and report of 
data conform to the clinical trial protocol, standard operating procedure, and relevant laws and 
regulations. Audits shall be performed by personnel who is not directly involved in the clinical 
trial. 
Regulatory department could perform supervision and administration of relevant documents, 
facilities, records and other aspects of the clinical trial of medical devices. 
11. Ethical Issues and Informed Consent of Clinical Trial 
11.1 Ethical considerations 
This study will be performed in accordance with the ethical guidelines of the Declaration of 
Helsinki, GCP for medical devices, all applicable laws and regulations to protect the rights, 
safety and health of the subjects. 
Before the start of the study, the clinical trial protocol, informed consent form, all information 
provided to the subjects, and other relevant materials related to the ethical review must be 
submitted to the Ethics Committee, which will take effect after review and approval or filing by 
the Ethics Committee. Investigators shall report the study progress to the Ethics Committee on a 
regular basis in accordance with the requirements of the Ethics Committee.  
Any modification to the clinical trial protocol, informed consent form and other documents shall 
be implemented after obtaining the written consent of the Ethics Committee again. 
If any document submitted to the Ethics Committee is modified after submission, the Ethics 
Committee must be notified in time. In addition, any serious/unexpected adverse events 

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occurring in the study that affect the rights and safety of subjects, or deviations from the clinical 
trial protocol must be reported to the Ethics Committee. 
11.2 Informed consent process 
All subjects are required to sign an informed consent form before starting to participate in the 
study. Informed consent form shall be obtained in accordance with the ethical guidelines of the 
Declaration of Helsinki, GCP, and other applicable laws and regulations. 
Clinical trial, inform the subjects of the ; Prior to the participation of the subjects in this clinical 
trial, the investigator shall explain in detail to each subject about the investigational medical 
device and the clinical trial, the possible benefits and predictable risks; after explaining the basic 
contents of this clinical trial, the investigator shall confirm that each subject who will participate 
in this trial understands the purpose of this trial, then the investigator shall request each subject 
to sign their name on the informed consent form and indicate the date, and the investigator sign 
his/her own name and indicate the date accordingly. 
Written informed consent shall be obtained from the subject’s guardian if the subject is an 
individual with no legal capacity or with limited legal capacity; an impartial witness shall be 
required to witness the whole informed consent process, sign his/her name on the informed 
consent form and indicate the date if the subject is lacking in reading ability.  
Each subject or his/her guardian must know that the participation in the trial is voluntary, and 
they may refuse to participate or have the right to withdraw from the trial at any stage of the trial 
and withdraw their informed consent without discrimination or retaliation, and their medical 
treatment and rights will not be affected etc. 
Subjects shall read and consider carefully before signing the informed consent form, and sign it 
after understanding the trial process and agreeing to participate in this study. The informed 
consent form will be provided in two copies, and one copy will be kept at the study center as the 
original data and one copy will be retained by the subject. Subjects whose informed consent is 
not obtained and/or subjects who do not sign the informed consent form will not be included in 
this trial. 
The informed consent process and specific matters in the ICF can be found in the ICF of this 
protocol. 
12. Regulations on Reporting of Adverse Events  
12.1 Definition and reporting requirements of adverse events 
12.1.1 Definition of adverse event 
Adverse event refers to any adverse medical event that occurs during the clinical trial of medical 
devices, whether or not it is related the investigational medical device. 
12.1.2 Classification of adverse event 
Mild: The adverse event is tolerable, does not affect the diagnosis and treatment, does not require 
special treatment, and has no impact on the subject’s health. 
Moderate: The adverse event is intolerable, requires special treatment, and has a direct impact on 
the subject's health. 
Severe: The adverse event endangers the subject’s life, causing death or disability, and 
immediate emergency treatment is required. 
12.1.3 Correlation of adverse event with devices 
Five criteria that investigators will use for judging the relationship between adverse events and 
study devices. Among them, "definitely related, probably related, and possibly related" will be 
determined to be adverse events related to the study devices. 

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(1) Definitely related: It conforms to the known reaction type of the device used, conforms to a 
reasonable time sequence after treatment, the adverse event cannot be explained by other reasons, 
the adverse event is alleviated or disappear after the treatment is stopped, the adverse event 
reappears after reuse, and the adverse event cannot be explained by the subject's current disease; 
(2) Probably related: It conforms to the known reaction type of the device used, conforms to a 
reasonable time sequence after treatment, the adverse event cannot be explained by other reasons, 
the adverse event is alleviated or disappear after the treatment is stopped, and it is impossible to 
judge whether the adverse event will occur again after reuse, the adverse event cannot be 
explained by the subject's current disease; 
(3) Possibly related: It conforms to the known reaction type of the device used, conforms to a 
reasonable time sequence after treatment, the adverse event cannot be explained by other reasons, 
the adverse event may be alleviated or disappear after treatment is stopped, and it is impossible 
to judge whether the adverse event will occur again after reuse, the adverse event can be 
explained by the subject's current disease; 
(4) Possibly unrelated: It conforms to the known reaction type of the device used, conforms to a 
reasonable time sequence after treatment, the adverse event can be explained by other reasons, 
the adverse event may be alleviated or disappear after treatment is stopped, and it is impossible 
to judge whether the adverse event will occur again after reuse, the adverse event can be 
explained by the subject's current disease; 
(5) Unrelated: It does not conform to the known reaction type of the device used, does not 
conform to a reasonable time sequence after treatment, the adverse event can be explained by 
other reasons, the adverse event does not alleviate or disappear after treatment is stopped, and the 
adverse event does not occur again after reuse, adverse events can be explained by the subject's 
current disease. 
12.1.4 Observation and recording of adverse events 
The investigator shall collect and record the adverse events from each subject during the period 
from the signing of informed consent form to the termination of follow-up. Any adverse event, 
regardless of its severity, or whether it is related to the medical device, is required to be recorded 
and described on the adverse event form for study medical records. Investigators need to 
determine the date of occurrence, severity, whether to take corresponding measures, and to judge 
the correlation between the adverse events and the medical devices. 
The subject undergoing such adverse events shall be followed up until the adverse events are 
recovered (return to normal state or to baseline state), or until the condition is stable, or until a 
reasonable explanation is available. 
12.1.5 Outcome of adverse events 
Investigators shall report the outcomes of adverse events recorded at the last visit in the eCRF, 
such as: 
(1) Symptoms disappear (with or without sequela, record the performance of sequela); 
(2) Symptoms improve; 
(3) Symptoms persist; 
(4) Death (record the direct cause of death and the time of death); 
(5) Unknown. 
12.1.6 Possible adverse events and their prevention and treatment 
Transient taste and/or odor disturbances may occur with the use of Pre-filled Flush Syringes. 
Special treatment is not necessary. 
12.2 Device defects and reporting 

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Device defects refer to the unreasonable risks of medical devices under normal use during 
clinical trials that may endanger human health and safety, such as label errors, quality issues, and 
malfunctions. 
If a device defect occurs during the trial, regardless of whether it causes injury to the 
subject/investigator, the investigator shall promptly notify the sponsor, the Ethics Committee, 
and clinical study monitor and other relevant personnel, and record the device defect in the 
eCRF. 
If adverse events or serious adverse events occur due to device defects, refer to the handling 
methods for adverse events or serious adverse events for proper handling. 
12.3 Definition of serious adverse events 
Serious adverse events (SAE) refers to those that result in death or serious deterioration of health 
conditions during clinical trial, including: 
Life-threatening diseases or injuries; 
Permanent defects of body structure or body function;  
Hospitalization or prolonged hospitalization required; 
Medical or surgical intervention required to prevent permanent defects of body structure or body 
function; 
Resulting in fetal distress, fetal death or congenital abnormality, congenital defects, etc. 
In this trial, subjects who will undergo a pre-planned medical/surgical procedure or are admitted 
to a hospital for a pre-planned medical/surgical procedure during their participation in the trial 
are not classified as SAEs. 
12.4 Reporting procedures, contact information 
In case of any serious adverse events occurring during the clinical trial, the investigators shall 
immediately take appropriate therapeutic measures for subjects, and report the serious adverse 
event to the sponsor, the administrative authority for clinical trial of medical device of the study 
site and the Ethics Committee within 24 hours after learning the occurrence of the serious 
adverse event; and the investigator shall follow up with the serious adverse event as per the 
clinical trial protocol and submit the follow-up report for the serious adverse event. 
When it is found that the risks of the medical device clinical trial exceed the possible benefits 
and it is necessary to suspend or terminate the clinical trial, the principal investigator shall report 
to the sponsor, the administrative department of the clinical trial institution of medical device, 
and the Ethics Committee, notify the subjects in a timely manner, and ensure that the subjects 
receive appropriate treatment and follow-up. 
The sponsor shall report to the other clinical trial institutions of medical device, Ethics 
Committee, and principal investigators participating in clinical trials, report to the drug 
regulatory departments of the province, autonomous region and municipality directly under the 
central government where the sponsor is located, report to the drug regulatory departments and 
health management departments of the province, autonomous region and municipality directly 
under the central government where the clinical trial institutions of medical device are located 
within 7 days of learning the death-causing or life-threatening medical device-related serious 
adverse event in the clinical trial, within 15 days of non-death-causing or non- life-threatening 
medical device-related serious adverse event and other serious safety risk information and take 
appropriate risk control measures; when information that may affect the safety of the subjects, 
the implementation of the medical device clinical trial or may change the approval of the Ethics 
Committee arises, modifications shall be made to the clinical trial protocol, informed consent 
form and other information provided to the subjects as well as other relevant documents in a 
timely manner and then submitted to the Ethics Committee for review. 

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When multiple serious adverse events related to the medical devices in the clinical trial occur or 
any other significant safety issues arise, the sponsor shall suspend or terminate the clinical trial, 
report to the administrative departments, ethics committees and principal investigators of all 
clinical trial institutions of medical device, report to the drug regulatory departments of the 
province, autonomous region and municipality directly under the central government where the 
sponsor is located, report to the regulatory authorities and health management departments of the 
province, autonomous region and municipality directly under the central government where the 
clinical trial institutions of medical device are located. 
Subjects who experience serious adverse events shall be followed up until their conditions return 
to normal, or premorbid conditions, or return to the condition deemed reasonable by the 
investigators, and the final follow-up report shall be reported in accordance with the reporting 
procedures for serious adverse events. 
Serious adverse events that occur at the final visit must also be reported in accordance with the 
reporting procedures for serious adverse events. 
In the event of recurrence, complications or worsening of a serious adverse event, the 
investigator shall follow up the primary serious adverse event and submit a follow-up report 
within 24 hours of receiving the information. If a new serious adverse event occurs at a different 
time period or is otherwise determined to be completely unrelated to the original serious adverse 
event due to other reasons, it must be reported as a new serious adverse event separately. 
Contacts 
Current unit 
Name 
Contact 
number 
E-mail 
BD Medical Technologies (Jiangsu) Co., 
Ltd. 
Ma Juanjuan
010-58139097
Jessica.Ma@bd.com 
GCP ClinPlus Co., Ltd. 
Xie Yuanyuan
13263414232 yuanyuan.xie@gcp-clinplus
.com
 
13. Deviation from Clinical Trial Protocol and Regulations for Clinical Trial 
Protocol Revision 
13.1 Definition of deviation 
Deviation refers to the situation where the requirements of the clinical trial protocol are not 
followed intentionally or unintentionally. 
Investigators shall strictly follow the clinical trial protocol and shall not intentionally deviate 
from the protocol or substantially change the protocol. Where there is emergency in which the 
subject faces the direct risk and which needs to be immediately tackled, report can be submitted 
in writing afterwards. 
If the investigator unintentionally fails to follow the clinical trial protocol, the investigator shall 
promptly report to the medical device clinical trial management department of the clinical trial 
institution after discovery, and be promptly informed by it to the sponsor and reported to the 
Ethics Committee. 
For all protocol deviations, investigators must record their cause, date, and severity in the 
original document. 
Protocol deviations include, but are not limited to: 
- Enrolled subjects do not meet the inclusion criteria or meet the exclusion criteria; 
- Failure to perform or inaccurately perform the treatment, follow-up or examination specified in 
this clinical trial protocol; 

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- Failure to report adverse events within the period specified in the clinical trial protocol. 
The severity of protocol deviation shall be classified by the following definitions: 
- Serious protocol deviation: protocol deviation that affects trial data and results, or endangers 
the rights and interests, safety or health of subjects. 
- Mild protocol deviation: protocol deviation that will not affect the trial data and results, nor will 
it jeopardize the rights and interests, safety or health of subjects. 
The sponsor will continue to review and evaluate the situation of protocol deviation, and if 
necessary, the sponsor will take appropriate corrective and preventive measures, including but 
not limited to: notifying, retraining the trial center or investigator, terminating the qualification 
of the trial center, and reporting to the local drug regulatory authorities and the National Medical 
Products Administration where the clinical trial institution is located. 
13.2 Measures to control deviations 
13.2.1 Sponsor 
The protocol will be designed with concise and clearly written descriptions and possible protocol 
deviations will be considered as much as possible, so that deviations are minimized in the design 
of the protocol and possible deviations can be easily and clearly identified and confirmed. 
In the meeting and training before the conduct of the trial, the implementation details of the 
protocol shall be trained to reduce the possible protocol deviation during the implementation. 
The rectification of the protocol deviation that has occurred shall be implemented in time. If 
necessary, the trial project shall be suspended in time, and the protocol or trial plan shall be 
revised. After the protocol is revised, the trial will be continued after the obtaining the approval 
of the Ethics Committee and the completion of retraining. 
13.2.2 Investigator 
The trial protocol will be designed and formulated together with the sponsor, and the investigator 
will fully discuss the feasibility of the protocol in the institution with the sponsor. 
The investigator shall explain to the subjects the importance of the compliance with protocol 
when informed consent is given. 
The investigator shall comply with protocol approved by the Ethics Committee. Once a deviation 
from the protocol is recognized, the situation shall be recorded and explained immediately and 
be reported to the relevant department as required. 
13.2.3 Subjects 
When signing the ICF, the trial protocol and requirements of the trial shall be explained in detail 
to the subjects, and the investigator shall inform the subjects of precautions such as operation 
and follow-up. 
13.2.4 Protocol deviation reporting 
If there is a deviation from the protocol, the investigator shall immediately report to the sponsor, 
and at the same time, to the Ethics Committee to determine whether the trial can be continued. 
13.3 The provisions of the clinical trial protocol amendments 
The medical device study protocol shall be based on the principle of maximizing the protection 
of subjects' rights and interests, safety and health, and shall be jointly designed and formulated 
by the medical institution in charge of the clinical trial and the sponsor, and shall be submitted to 
the Ethics Committee for approval before implementation. If there is any modification to the 
study protocol, informed consent form and case report form during the study, the revised 
materials must be approved by the Ethics Committee before proceeding with the clinical trial. 
 

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14. Direct Access to Source Data and Documents 
Source data refers to the original records of clinical findings, observations and other activities in 
clinical trials and all the information in their approved copies, which can be used for clinical trial 
reconstruction and evaluation. 
Source document refers to printed, visual, or electronic documents containing source data. 
The authorized monitor has the right to access and verify the source data or source documents of 
the subjects to determine whether the investigator conduct clinical trials in accordance with 
protocol requirements, and whether the source data or source documents are timely recorded in 
the subjects' medical records. The monitor needs to confirm that the source data or source 
documents are traceable and verifiable. At the same time, the data filled in the eCRF shall 
correspond to the source data or source documents. 
When any person involved in the clinical trial questions the clinical trial data, the investigator 
shall provide the source data or source documents in time for the relevant personnel to verify and 
carefully answer the relevant questions. 
The source data or source documents shall be maintained for 10 years after the end of the clinical 
trial in accordance with relevant laws and regulations. If the regulations are updated, the 
retention period shall be updated accordingly. Destruction requires the signature of the sponsor 
for confirmation and shall meet the requirements of relevant laws and regulations. 
15. Contents to be Covered in the Clinical Trial Report 
The clinical trial report shall fully, completely and accurately reflect the clinical trial results, and 
the safety and efficacy data of the clinical trial report shall be consistent with the clinical trial 
source data. 
The clinical trial report generally contains general information about the clinical trial of medical 
devices, implementation, statistical analysis methods used, clinical trial results, adverse events 
and device defect report and their handling information, analysis and discussion of clinical trial 
results, clinical trial conclusion, ethical information description, issued found and suggestions for 
improvement etc. 
16. Confidentiality Principle 
All data generated in this study is confidential to the sponsor. The sponsor has the right to 
publish the results of the study. The investigators shall maintain the confidentiality of 
information and data related to this trial, and the investigators must be aware of the potential 
commercial value to the sponsor of scientific or medical information derived from this trial. 
If the investigators expect to publish the information related to this trial or the conclusions drawn 
from the trial, it is necessary to consult with the sponsor in advance and obtain the written 
consent of the sponsor, and provide the attachment to the manuscript for review by the sponsor. 
The sponsor has the right to request the investigators not to publish information about the trial 
before the trial product is approved for marketing. 
The sponsor has the right to publish or release information and data related to this trial, or to 
report it to the drug regulatory authorities. Sponsors shall obtain the investigator's prior consent 
if they wish to include the investigator's name in publications, releases or advertisements. 

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All personal information of the subjects participating in this clinical trial is confidential, however, 
the administrative department of the clinical trial institutions of the medical device, the Ethics 
Committee, the drug regulatory authorities, the health management departments or monitors, 
auditors are allowed to access the information of the subjects according to the specified 
procedures. Participating investigators, staff and sponsors jointly take intervention measures to 
strictly protect the privacy of subjects and the confidentiality of their related information. 
17. Responsibilities of All Parties 
17.1 Responsibilities of sponsor 
The sponsor is responsible for the truthfulness and compliance of the clinical trial. If the sponsor 
is a foreign organization, an enterprise legal person in China shall be designated as an agent in 
accordance with relevant laws and regulations, and the agent shall assist the sponsor to perform 
its responsibilities. 
The sponsor's quality management system shall cover the entire process of the clinical trial of 
medical devices, and the quality management measures shall be adapted to the risks of the 
clinical trial. 
Before the initiation of the clinical trial of medical devices, the sponsor shall ensure that the 
product design has been finalized, complete the pre-clinical study of the investigational medical 
device, including performance validation and qualification, product inspection report based on 
product technical requirements, risk-benefit analysis, etc., and the results should be able to 
support the clinical trial of the medical device; select the registered clinical trial institutions of 
medical device, majors and principal investigators according to the characteristics of the 
investigational medical device; organize the formulation of investigator’s brochure, clinical trial 
protocol, informed consent form, case report form, standard operating procedures and other 
related documents, and provide them to clinical trial institutions of medical device and principal 
investigators. 
The sponsor shall sign contracts with the clinical trial institutions of medical device and the 
principal investigator to clarify the rights and obligations of each party in the clinical trial of the 
medical device. 
The sponsor shall file the clinical trial project with the drug regulatory department of the 
province, autonomous region or municipality directly under the central government where the 
sponsor is located after the clinical trial of the medical device has passed the ethics review and 
signs a contract with the clinical trial institutions of the medical device. 
Before the clinical trial of the medical device begins, the sponsor shall be responsible for 
organizing training related to the clinical trial of the medical device, such as the principle, scope 
of application, product performance, operation method, installation requirements, technical 
indicators, and clinical trial protocol, standard operating procedures for the medical device and 
other related documents. 
The sponsor shall provide the investigational medical device free of charge, and ensure that the 
investigational medical device shall be produced in accordance with the relevant requirements of 
the Good Manufacturing Practice for Medical Devices and of accepted quality; determine the 
transportation conditions, storage conditions, storage time, expiry date, etc. of the investigational 
medical device; the investigational medical device shall be properly packaged and stored in 
accordance with the requirements of the clinical trial protocol; the product information shall be 
marked on the packaging label, with an easily identifiable and correctly coded mark, indicating 
that it is only used for clinical trial of the medical device; after clinical trial of the medical device 
is approved by the Ethics Committee, the sponsor is responsible for transporting the 
investigational medical device to the clinical trial institution of the medical device under 
specified conditions; for investigational medical devices recovered from clinical trial institutions 

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of medical devices, the sponsor is responsible for maintaining records of recovery and disposal. 
The sponsor shall pay the cost related to the clinical trial of medical devices for the subjects. 
When a subject suffers injuries or death related to the clinical trial of the medical device, the 
sponsor shall bear the corresponding treatment costs, compensation or indemnity, but not 
including the injuries caused by the investigator's and the clinical trial institution of medical 
device's own negligence and the subject's own disease progression. 
The sponsor shall be responsible for the evaluation and reporting of safety information during 
medical device trial. 
The sponsor shall assume the responsibility for the monitoring of clinical trials of medical 
devices, formulate the standard operating procedures for monitoring, and select monitors who 
meet the requirements to perform the monitoring duties. 
The sponsor may organize auditors who are independent of medical device clinical trials and 
have corresponding training and experience to conduct audits on the implementation of clinical 
trials and assess whether the clinical trials comply with the clinical trial protocol, GCP and 
relevant laws and regulations. 
The sponsor shall ensure that the implementation of the clinical trial of medical devices is carried 
out in accordance with the clinical trial protocol, and if it is found that the clinical trial 
institutions of medical devices and investigators fail to comply with the clinical trial protocol, 
GCP and relevant laws and regulations, the sponsor shall point out and correct them in a timely 
manner; if the non-compliance is serious or persists, the clinical trial institution and the 
investigator shall be terminated from continuing to participate in the clinical trial, and a written 
report shall be submitted to the drug regulatory department of the province, autonomous region, 
or municipality directly under the central government where the clinical trial institution is 
located.  
The sponsor shall, within 10 working days after the medical device clinical trial is suspended, 
terminated or completed, report in writing to all the principal investigators, the administrative 
department of the clinical trial institution of medical device, and the Ethics Committee. 
The sponsor shall, within 10 working days after the termination or completion of the clinical trial 
of medical devices, report to the drug regulatory department of the province, autonomous region 
or municipality directly under the central government where the sponsor is located. 
17.2 Responsibilities of clinical trial institutions of medical device 
The administrative department of clinical trial institution of medical device shall be responsible 
for filling in, managing and changing the clinical trial institution of medical device’s registration 
information in the registration management information system for clinical trial institutions of 
clinical trial, including the clinical trial specialty, principal investigator and other information; 
responsible for submitting the summary report on the implementation of clinical trials of medical 
devices in the previous year online in the registration system; responsible for organizing the 
evaluation of the qualifications of the principal investigators of the clinical trial and completing 
its filing before the ethics committee reviews the clinical trial of medical devices. 
Clinical trial institutions of medical device shall establish a quality management system, 
covering the entire process of the implementation of medical device clinical trials, to ensure that 
the principal investigators perform their clinical trial-related duties, to ensure that subjects 
receive proper medical treatment, and to ensure the authenticity of the data generated by the 
trials. 
Before accepting clinical trials of medical devices, clinical trial institutions of medical device 
shall evaluate relevant resources according to the characteristics of the investigational medical 
devices to ensure that they are provided with proper qualifications, personnel, facilities, and 
conditions. 

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Clinical trial institutions of medical device and investigators shall cooperate with the monitoring 
and audits organized by the sponsor, as well as the inspections carried out by the drug regulatory 
department and the health management department. 
Clinical trial institutions of medical device shall properly maintain clinical trial records and basic 
documents in accordance with relevant laws and regulations and contracts signed with the 
sponsor. 
17.3 Responsibilities of investigators 
The principal investigator shall ensure that the clinical trial of medical device follows the latest 
version of the clinical trial protocol agreed by the Ethics Committee; carry out the clinical trial of 
medical devices in accordance with the provisions of GCP and relevant laws and regulations. 
The principal investigator may, according to the needs of the clinical trial of medical device, 
authorize investigators who have received training related to clinical trials to organize subject 
recruitment, informed consent, screening and follow-up; management and use of investigational 
devices and control devices; management and use of biological samples; handling of adverse 
events and device defects; clinical trial data recording and case report form filling, etc. 
Investigators participating in clinical trials of medical devices shall: have the corresponding 
professional technical qualifications, training experience and relevant experience to undertake 
clinical trials of medical devices; participate in the training related to the clinical trial of the 
medical device organized by the sponsor, and participate in the clinical trial of the medical 
device within the scope authorized by the principal investigator; be familiar with the principle, 
scope of application or intended use, product performance, operation method, installation 
requirements and technical indicators of the investigational medical device, and understand the 
relevant information of the preclinical study of the investigational medical device; fully 
understand and comply with the clinical trial protocol, GCP and relevant laws and regulations, as 
well as responsibilities related to clinical trials of medical devices; master the prevention and 
emergency treatment methods of risks that may arise in clinical trials. 
Investigators shall abide by the ethical guidelines and relevant ethical requirements of the 
Declaration of Helsinki of the World Medical Assembly. 
Investigators are responsible for the management of the test medical device and the control 
medical device (if applicable) provided by the sponsor, and shall ensure that it is only used for 
the subjects participating in the clinical trial of the medical device, and is stored and kept as 
required during the clinical trial. After the clinical trial is completed or terminated, they shall be 
disposed in accordance with relevant laws and regulations and the contract with the sponsor. 
Investigators shall ensure that the collection, processing, preservation, transportation, and 
destruction of biological samples in medical device clinical trials comply with the clinical trial 
protocol and relevant laws and regulations. 
When an adverse event occurs in the clinical trial of the medical device, the investigators shall 
provide the subject with adequate and timely treatment; when the subject develops a concurrent 
disease requiring treatment, the investigators shall promptly inform the subject. Investigators 
shall record adverse events and device defects found during the clinical trial of medical device. 
Investigators shall report safety information in the clinical trials of medical device in a timely 
manner. 
The principal investigator shall deal with the received safety information in a timely manner. 
The principal investigator shall report the progress of the clinical trial of medical device to the 
Ethics Committee as scheduled, and promptly report events affecting the rights and safety of 
subjects or deviations from the clinical trial protocol. 
Clinical trial institutions of medical device and investigators shall report in writing to the drug 

Device Name: Pre-filled Flush Syringes 
Protocol No.: MDS-21FLUSHCN01/NCT04719377 
Version No. / Version Date: V1.0/May 26, 2022 
 
38 
regulatory department of the province, autonomous region or municipality directly under the 
central government where the sponsor is located for the sponsor's serious or persistent violation 
of GCP and relevant laws and regulations, or the requirement to change the trial data and 
conclusions. 
17.4 Responsibilities of CRO 
The CRO shall comply with the current regulations and guidelines such as the GCP for medical 
devices, the Declaration of Helsinki, and the obligations and responsibilities for the contract 
research organization in the trial protocol and sponsor contract. 
The CRO shall be responsible for the related work of the management of the trial project and 
clinical monitoring affairs, establish the quality control and quality assurance system for the 
clinical trial, and assign professionals personnel to monitor the whole process of the clinical trial 
in accordance with the requirements of the company's quality system to ensure the authenticity, 
completeness and standardization of the entire trial process. 
 
18. Other Contents Required to be Described 
18.1 Basic document management 
Clinical trial institutions, investigators, and sponsors shall establish a basic document 
preservation system. The basic documents of clinical trial are divided into three parts according 
to the clinical trial stage: the document of preparation stage, the document of progress stage and 
the document of termination or post-completion. 
Investigators shall properly maintain the basic clinical trial documents during the clinical trial of 
medical devices. The clinical trial institutions shall preserve the clinical trial data for 10 years 
after the completion or termination of the clinical trial. The Ethics Committee shall keep all 
records of the ethics review until 10 years after the completion or termination of clinical trials of 
medical devices. The sponsor shall keep the basic documents of the clinical trial until there is no 
use of this medical device. 
The basic documents of clinical trial can be used to evaluate the implementation of this 
specification and the relevant requirements of the drug regulatory authorities by the sponsors, 
clinical trial institutions and investigators. The drug regulatory department can inspect the basic 
documents of clinical trials. 
18.2 Finance and insurance 
The sponsor is responsible for the cost of medical treatment and corresponding compensation of 
subjects participating in clinical trials for injury or death related to the clinical trials. The sponsor 
shall provide the investigators and the clinical trial institutions with legal and financial insurance 
or guarantees, related to the clinical trial, which should be commensurate with the nature and 
degree of risk of the clinical trial. However, it does not cover injury caused by the investigators 
and the clinical trial institution's own negligence. 

Device Name: Pre-filled Flush Syringes 
Protocol No.: MDS-21FLUSHCN01/NCT04719377 
Version No. / Version Date: V1.0/May 26, 2022 
 
39 
Investigator’s Statement 
I agree: 
1. To carry out this clinical trial in strict accordance with the Declaration of Helsinki, the current 
laws and regulations in China and the requirements of the trial protocol. 
2. To accurately record all required data in the Case Report Form (CRF) and provide cooperation 
in the completion of clinical trial reports. 
3. To only use the investigational medical devices for this clinical trial. Completely and 
accurately record the receipt and use of the investigational medical devices during the clinical 
trial and save the records. 
4. To allow sponsors to authorize or dispatch monitors, auditors and regulatory authorities to 
monitor, audit and inspect the clinical trial. 
5. To strictly fulfill the clinical trial contract/protocol terms signed by the parties. 
I have read the clinical trial protocol and the statement above, and I agree with all of them. 
Principal investigator 
 
 
 
Signature 
 
(YYYY/MM/DD) 
 
 Clinical trial institution of medical device 
 
 
Signature and seal 
 
(YYYY/MM/DD) 
 
Sponsor 
 
 
 
Signature 
 
(YYYY/MM/DD)