FDA Adverse Event
Malfunction
Summary report: N
BECTON DICKINSON AND CO.
MDR report key: 200749
·
Received December 4, 1998
Report
- Report Number
- MW1015116
- Event Type
- Malfunction
- Date Received
- December 4, 1998
- Report Date
- December 4, 1998
- Manufacturer
- BECTON DICKINSON & CO.
- Product Code
- FMF
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- MD, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
EVENT IS ONGOING. A 60 ML SYRINGE, FLUID LEAK THROUGH RUBBER STOPPER ON PLUNGER. TWELVE OUT OF TWENTY LEAKED. MINIMAL PRESSURE USED. SOLUTION SALINE 0.9% LEAK WHILE WITHDRAWING SOLUTION AND ALSO WHILE PUSHING SOLUTION OUT OF SYRINGE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BECTON DICKINSON AND CO. | 60CC SYRINGE | FMF | BECTON DICKINSON & CO. | * | 8J634 | |
| 2 | BECTON DICKINSON AND CO. | 60CC SYRINGE | FMF | BECTON DICKINSON & CO. | * | 8J630 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |