FDA Adverse Event
Malfunction
Summary report: N
BD PATIENT ROOM SHARPS COLLECTOR
MDR report key: 1171559
·
Received September 17, 2008
Report
- Report Number
- 2029238-2008-00003
- Event Type
- Malfunction
- Date Received
- September 17, 2008
- Date of Event
- August 20, 2008
- Report Date
- September 17, 2008
- Manufacturer
- BD SHARPS DISPOSAL SYSTEMS,
- Product Code
- MMK
- PMA / PMN Number
- K943139
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
SHARPS COLLECTORS ARE PUNCTURE RESISTANT. THEY ARE NOT, HOWEVER PUNCTURE PROOF. THEY ARE ROUTINELY CHECKED FOR WALL PENETRATION AND WALL THICKNESS. LABEL STATES THAT TO AVOID INJURY, EXAMINE THE COLLECTOR CAREFULLY BEFORE YOU FILL, CARRY, OR DISPOSE OF IT.
Description of Event or Problem · 1
WHILE ATTEMPTING TO DISPOSE OF A SHARP IN COLLECTOR, NURSE SUSTAINED NEEDLE STICK INJURY RESULTING FROM PENETRATION OF NEEDLE THROUGH FRONT WALL OF DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BD PATIENT ROOM SHARPS COLLECTOR | 5.4 QT HORIZONTAL ENTRY SHARPS COLLECTOR | MMK | BD SHARPS DISPOSAL SYSTEMS, | NA | 7325525 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |