FDA Adverse Event
Malfunction
Summary report: N
INSULIN SYRINGE
MDR report key: 18961
·
Received January 13, 1995
Report
- Report Number
- MW1004754
- Event Type
- Malfunction
- Date Received
- January 13, 1995
- Date of Event
- December 30, 1994
- Report Date
- January 5, 1995
- Manufacturer
- RUGBY LABORATORIES, INC.
- Product Code
- FMF
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
A NEW AND UNUSED NEEDLE WAS BENT AND PROTRUDING THROUGH THE CAP ON THE SYRINGE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INSULIN SYRINGE | INSULIN SYRINGE | FMF | RUGBY LABORATORIES, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |