UNKNOWN INJECTION NEEDLE
Report
- Report Number
- 1911916-2025-00217
- Event Type
- Malfunction
- Date Received
- March 19, 2025
- Date of Event
- March 10, 2025
- Report Date
- April 9, 2025
- Manufacturer
- BECTON DICKINSON
- Product Code
- FMI
- PMA / PMN Number
- K941562
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
FOLLOW UP MDR FOR CORRECTION: D TAB UPDATED: UNKNOWN INJECTION NEEDLE; UNKNOWN MATERIAL ; UNKNOW LOT NUMBER.
INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.
PR (B)(4) FOLLOW UP. IT WAS REPORTED THE INJECTION NEEDLE SEPARATED. AS A SAMPLE WAS NOT RETURNED, A THOROUGH SAMPLE EVALUATION COULD NOT BE PERFORMED. TO AID IN THE INVESTIGATION, ONE PHOTO WAS RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. THE PHOTO SHOWS A SYRINGE WITH WHAT APPEARS TO BE A CAP OR NEEDLE HUB ASSEMBLED TO IT. NO OTHER INFORMATION COULD BE OBTAINED FROM THE PHOTO. BASED ON THE INVESTIGATION WITH THE PHOTO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED. WITHOUT THE ACTUAL PHYSICAL SAMPLE ANALYSIS, A PROBABLE ROOT CAUSE COULD NOT BE OFFERED.
NO ADDITIONAL INFORMATION.
MATERIAL #305200. LOT #2172517. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. "THE NEEDLE CAME OFF WHILE STAFF WAS DRAWING UP THE MEDICATION." BASED ON THE PHOTO PROVIDED BY THE FACILITY, IT APPEARS THAT THE COMPLAINT IS REGARDING THE NEEDLE SHAFT DETACHING FROM THE NEEDLE BASE.
THERE WAS NO PATIENT HARM OR COMPLICATIONS ARISING FROM THIS INCIDENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1211856 | UNKNOWN INJECTION NEEDLE | NEEDLE, HYPODERMIC, SINGLE LUMEN | FMI | BECTON DICKINSON | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |