FDA Adverse Event
Malfunction
Summary report: N
NEEDLE PROTECTOR
MDR report key: 982248
·
Received December 26, 2007
Report
- Report Number
- 982248
- Event Type
- Malfunction
- Date Received
- December 26, 2007
- Date of Event
- November 1, 2007
- Report Date
- December 26, 2007
- Manufacturer
- SARSTEDT, INC.
- Product Code
- FMI
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- SD, US
Narratives
Description of Event or Problem · 1
NURSE HAD GIVEN AN INJECTION TO A PATIENT AND WAS ACTIVATING THE SAFETY DEVICE WHEN THE NEEDLE POKED THROUGH THE SAFETY PROTECTOR AND STUCK THE NURSE. NURSE SAID THIS HAS HAPPENED BEFORE WITH THIS PARTICULAR DEVICE, BUT SHE HAD NOT GOTTEN STUCK THEN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NEEDLE PROTECTOR | NEEDLE, SAFETY | FMI | SARSTEDT, INC. | * | 6626002 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 46 YR |