FDA Adverse Event
Malfunction
Summary report: N
BD CONVENTIONAL NEEDLE
MDR report key: 18794278
·
Received February 27, 2024
Report
- Report Number
- 3002682307-2024-00036
- Event Type
- Malfunction
- Date Received
- February 27, 2024
- Date of Event
- February 7, 2024
- Report Date
- May 3, 2024
- Manufacturer
- BECTON DICKINSON, S.A.
- Product Code
- FMI
- PMA / PMN Number
- UNK
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
CORRECTION: USED ON AN ANIMAL, NOT MDR REPORTABLE.
Additional Manufacturer Narrative · 0
H.3. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED. B3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD.
Description of Event or Problem · 0
NA.
Description of Event or Problem · 0
IT WAS REPORTED THAT BD CONVENTIONAL NEEDLE; NEEDLE BROKE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM DUTCH TO ENGLISH: I HAVE BEEN IN CONTACT WITH YOU BEFORE ABOUT A NEEDLE BREAKING OFF WHILE INJECTING A CAT. THIS HAS JUST HAPPENED AGAIN, AND I WAS JUST ABLE TO REMOVE THE NEEDLE FROM THE CAT. IT IS AGAIN THE SAME TYPE OF NEEDLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1224891 | BD CONVENTIONAL NEEDLE | NEEDLE, HYPODERMIC | FMI | BECTON DICKINSON, S.A. | 220923 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |