FDA Adverse Event
Other
Summary report: N
BBRAUN MEDICAL
MDR report key: 2667090
·
Received December 23, 2005
Report
- Report Number
- 9611612-2005-00005
- Event Type
- Other
- Date Received
- December 23, 2005
- Date of Event
- March 15, 2004
- Report Date
- September 29, 2005
- Manufacturer
- PAJUNK GMBH
- Product Code
- BSP
- Removal / Correction Number
- UNK
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
THE 20 GA INTRODUCER PLACED IN THE PT'S BACK. NEEDLE DISCONNECTED FROM HUB. PHYSICIAN TURNED TO GET HEMOSTATS TO REMOVE REMAINING NEEDLE WHEN PT MOVED, CAUSING NEEDLE TO MIGRATE INTO PT'S SKIN. NEEDLE HAD TO BE REMOVED WITH SCALPEL / SURGICAL PROCEDURE. PT RECOVERED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BBRAUN MEDICAL | INTRODUCER CANNULA 24 G BSP | BSP | PAJUNK GMBH | 021151-30LB | 60473291 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |