Needlesticks  
 
Medical Device Reporting 
Guidance for User Facilities, 
Manufacturers, and Importers
 
 
 
 
 
Document issued on: November 12, 2002 
 
 
 
 
This document supersedes MDR Guidance Document and Exemption  
No. 3  Needlesticks and Blood Exposure E1996003 
 
 
 
 
 
 
U.S. Department Of Health and Human Services 
Food and Drug Administration 
Center for Devices and Radiological Health 
 
 Reporting Systems Monitoring Branch 
 
Division of Surveillance Systems 
Office of Surveillance and Biometrics 
 
 
   
  Preface 
 
 
Public Comment 
 
Comments and suggestions may be submitted at any time for Agency consideration to Dockets 
Management Branch, Division of Management Systems and Policy, Office of Human Resources 
and Management Services, Food and Drug Administration, 5630 Fishers Lane, Room 1061, 
(HFA-305), Rockville, MD, 20852.  When submitting comments, please refer to the exact title of 
this guidance document.  Comments may not be acted upon by the Agency until the document is 
next revised or updated. 
 
For questions regarding the use or interpretation of this guidance contact the Reporting Systems 
Monitoring Branch at (301) 594-2735, by FAX at (301) 827-0038 or email at 
rsmb@cdrh.fda.gov or mail at: 
 
Food and Drug Administration 
Center for Devices and Radiological Health 
Division of Surveillance Systems (HFZ-533) 
Medical Device Reporting (MDR) Inquires 
1350 Piccard Drive 
Rockville, Maryland 20850 
 
 
Additional Copies 
 
Additional copies are available from the Internet at: 
http://www.fda.gov/cdrh/osb/guidance/250.pdf, or CDRH Facts-On-Demand.  In order to 
receive this document via your fax machine, call the CDRH Facts-On-Demand system at 
800-899-0381 or 301-827-0111 from a touch-tone telephone.  Press 1 to enter the 
system.  At the second voice prompt, press 1 to order a document.  Enter the document 
number 250 followed by the pound sign (#).  Follow the remaining voice prompts to 
complete your request.   
Needlesticks - Medical Device Reporting 
Guidance 
 
This document is intended to provide guidance.  It represents the Agencys current 
thinking on this topic.  It does not create or confer any rights for or on any person and 
does not operate to bind Food and Drug Administration (FDA) or the public.  An 
alternative approach may be used if such approach satisfies the requirements of the 
applicable statute, regulations, or both. 
 
 
 
Introduction 
 
On August 9, 1996, the FDA published a guidance document entitled MDR Guidance Document 
and Exemption  Needlesticks and Blood Exposure  E1996003.  The document was designed to 
provide guidance to user facilities, manufacturers, and importers to use for determining when an 
adverse event involving a needlestick, or a device intended to prevent a needlestick, would require 
the submission of a mandatory medical device death, serious injury, or malfunction report to the 
FDA.   
 
Needlestick-related injuries, and malfunctions of devices intended to prevent needlesticks, that 
result in occupational exposure to bloodborne pathogens, such as human immunodeficiency virus 
(HIV), hepatitis B virus (HBV), and hepatitis C virus (HCV), continue to be an important public 
health concern.   
 
Healthcare workers are especially at risk from bloodborne pathogen exposure on a daily basis and 
may not be aware that needlestick-related adverse events are reportable to the FDA by user 
facilities, manufacturers and importers.  In addition, healthcare workers may not be aware that FDA 
has a voluntary reporting program they can use to report their needlestick-related events. 
 
Due to continuing health concerns related to needlesticks and the devices intended to prevent 
needlesticks, the FDA decided to update its 1996 Needlestick Guidance document.  The purpose 
of this revised Needlestick Guidance document is to provide user facilities, manufacturers, and 
importers with user-friendly information about their roles and obligations for reporting adverse 
events related to these products.  The revised document also provides information for healthcare 
workers to report adverse events to the FDA through the voluntary MedWatch reporting system.  
This document conforms to the requirements of the Good Guidance Practices (GGP) regulation. 
  The Least Burdensome Approach 
 
We believe we should consider the least burdensome approach in all areas of medical 
device regulation.  This guidance reflects our careful review of the relevant scientific and 
legal requirements and what we believe is the least burdensome way for you to comply with 
those requirements.  However, if you believe that the information requested in the guidance 
is not relevant to the decision-making process or that an alternative approach would be less 
burdensome, please contact us so we can consider your point of view.  You may send your 
written comments to the contact person listed in the preface to this guidance or to the 
CDRH Ombudsman.  Comprehensive information on CDRH's Ombudsman, including ways 
to contact him, can be found on the Internet at http://www.fda.gov/cdrh/ombudsman/ 
 
 
 
 
 
Needlesticks - Medical Device Reporting Guidance  
 
 
A.  What are the mandatory requirements, under 21 CFR Part 803, for device user 
facilities, importers, and manufacturers to report needlestick-related adverse events to 
the FDA? 
 
The Medical Device Reporting (MDR) regulation, 21 CFR Part 803, requires that user facilities 
must submit medical device adverse event reports, on FDA Form 3500A, to the FDA and the 
device manufacturer whenever the facility become aware that a device used at the facility may have 
caused or contributed to a patient death.  User facilities must also report adverse events to the 
device manufacturer or to FDA (if the manufacturer is unknown) whenever they become aware that 
a device may have caused or contributed to a serious injury to a patient of the facility.   
 
In addition, user facilities are required to submit an annual report on FDA Form 3419 summarizing 
the reports submitted by the user facility during the reporting period. 21 CFR Part 803.3 
 
The MDR regulation requires that device importers must submit medical device adverse event 
reports, on FDA Form 3500A, to the FDA and the device manufacturer whenever they become 
aware that one of their imported devices may have caused or contributed to a death or serious 
injury.  Device importers must also submit adverse event reports to the device manufacturer 
whenever they become aware that one of their imported devices has malfunctioned, and such a 
malfunction would be likely to cause or contribute to a death or serious injury if it were to recur. 
 
  The MDR regulation requires that device manufacturers must submit medical device adverse event 
reports to the FDA, on FDA Form 3500A, whenever the manufacturer becomes aware that one of 
their manufactured devices may have caused or contributed to a death or serious injury.  Device 
manufacturers must also submit adverse event reports to FDA whenever they become aware that 
one of their manufactured devices has malfunctioned, and such a malfunction would be likely to 
cause or contribute to a death or serious injury if it were to recur. 
 
In addition, the manufacturer is required to submit a baseline report, on FDA Form 3417, for a 
device when the device model is first reported as required by Parts 803.50 and 803.52.      21 
CFR Part 803.55 
 
 
 
B.  Where can I find more information about the mandatory reporting requirements for 
device user facilities, importers and manufacturers? 
 
The mandatory MDR requirements, forms, instructions for filling out the forms, guidance documents 
and Federal Register notices can be found on the Reporting Problems with Medical Devices 
homepage at:    http://www.fda.gov/cdrh/mdr/ 
 
You may also submit questions to the Reporting Systems Monitoring Branch, Division of 
Surveillance Systems, Office of Surveillance and Biometrics e-mail account at:  rsmb@cdrh.fda.gov 
or by contacting them directly at (301) 594-2735. 
 
 
C.  When to I have to report a needlestick-related event reportable under 21 CFR Part 
803? 
 
A needlestick-related event is reportable as a death, serious injury or malfunction as detailed below: 
 
1.  A death report should be submitted by a user facility, importer and manufacturer if the device 
may have caused or contributed to the death of the individual.  
 
2.  A serious injury report should be submitted by a user facility, importer and manufacturer if the 
device resulted in an injury to an individual and the injury was life-threatening, resulted in 
permanent impairment of a body function or permanent damage to a body structure, or 
necessitated medical or surgical intervention to preclude permanent impairment of a body 
function or permanent damage to a body structure.  
 
3.  A device malfunction report should be submitted by an importer and manufacturer if the device 
failed to perform as intended and would be likely to cause or contribute to a death or serious 
injury if the needlestick event recurred.   
  If a person who is exposed to infectious materials via a needlestick that resulted from a device 
failure is subsequently treated medically or surgically to prevent permanent impairment, then the 
event becomes reportable by the user facility, importer, and manufacturer as a serious injury report. 
 
We do not consider first aid to constitute medical intervention, and this type of intervention will not 
require an MDR report. Examples of first aid are the application of a bandage or simple cleaning of 
the site of a needlestick. In addition, we do not consider an in-vitro diagnostic test for blood-borne 
diseases to constitute medical intervention. However, administration of a tetanus shot, a gamma 
globulin shot or stitches is considered medical intervention.  This type of intervention triggers the 
submission of a mandatory serious injury adverse event report by a device user facility, importer, or 
manufacturer. 
 
D. What is a medical device malfunction? 
 
A malfunction is the failure of a device to meet its performance specifications or to perform as 
intended.  If you are an importer or manufacturer of a device, you must report a malfunction when it 
is likely to cause or contribute to a death or serious injury if the malfunction were to recur.   
 
Once a malfunction has caused or contributed to a death or serious injury, a presumption that the 
malfunction is likely to cause or contribute to a death or serious injury has been established. This 
presumption will continue until the malfunction has caused or contributed to no further deaths or 
serious injuries for a period of two years, or valid data shows that the likelihood of another death or 
serious injury because of the malfunction is remote. 
 
A malfunction that is or can be corrected during routine service or device maintenance should be 
reported if the malfunction is likely to cause or contribute to a death or serious injury if it were to 
recur. 
 
You do not need to report a malfunction if it is not likely to result in a death or serious injury. 
 
If you are a user facility, you are not required to report any device malfunctions.  However, we 
encourage you to report device malfunctions to the device manufacturer and/or to the FDA through 
the voluntary MedWatch program. 
 
E.  Do I have to report a needlestick-related event that involves blood spillage or 
splattering? 
 
You do not need to report a device-related blood spillage or splattering event unless the incident is 
the result of a device malfunction.  If you are a manufacturer or an importer, you should report any 
spillage or splattering malfunction event if a recurrence is likely to cause or contribute to a death or 
serious injury. 
  F.  Do I have to report a needlestick-related event due solely to user error? 
 
It depends on the severity of the event.  Events involving a death or a serious injury where user error 
may have caused or contributed to a needlestick-related event are reportable by a user facility, 
importer, and manufacturer. 
 
 
G. As a manufacturer, what type of follow-up investigation should I conduct for events 
involving needlestick-related devices? 
 
We require that you make a good faith effort to obtain information about the event. 21 CFR 
803.50.  You should document all follow-up attempts and reasons why any of the required MDR 
information could not be obtained.  You should include in your file a record of each attempt to 
obtain information, and the reporters responses. We may review the documentation contained in 
your files to determine whether you have made a reasonable attempt to follow up and obtain the 
required information. If your firm determines that the event is not reportable under the MDR 
regulation, then your files should contain documentation supporting this decision. 
 
The follow-up investigation should focus on obtaining as much information as possible. 
 
H. How can I submit voluntary MedWatch reports concerning needlestick-related events 
to FDA when those events are not required to be reported by 21 CFR Part 803? 
 
User facilities are not required to submit mandatory malfunction adverse event reports involving 
needlesticks to the FDA.  However, we encourage healthcare workers to report malfunctions 
involving needlestick-related events to the device manufacturer or to the FDA through the FDA 
MedWatch Voluntary Reporting Program on FDA Form 3500.  Information about the FDA 
MedWatch Voluntary Reporting program and the Form FDA 3500 Voluntary Reporting Form can 
be found on the FDA MedWatch home page at:  www.fda.gov/medwatch/.   A voluntary report 
can be filled out on line by accessing the MedWatch homepage and clicking on Submit Reports 
or by direct access at:  www.accessdata.fda.gov/scripts/medwatch/.  In lieu of submitting a 
voluntary report via the internet, you may report to us by dialing 1-800-FDA-1088 or 
     
1-240-276-3000.