FDA Adverse Event
Malfunction
Summary report: N
POWERPICC SOLO HF CATHETER W/SHERLOCK 3CG (TPS) STYLET:
MDR report key: 3111980
·
Received May 7, 2013
Report
- Report Number
- 3006260740-2013-00212
- Event Type
- Malfunction
- Date Received
- May 7, 2013
- Date of Event
- April 6, 2013
- Report Date
- April 18, 2013
- Manufacturer
- C. R. BARD INC. (BASD)
- Product Code
- LJS
- PMA / PMN Number
- K091324
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVAL, AS THE DEVICE WAS DISCARDED AFTER THE EVENT OCCURRED. A LOT HISTORY REVIEW (LHR) OF REXB0800 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.
Description of Event or Problem · 1
PICC STOPPED FUNCTIONING AND PER TRAY WAS FOUND TO HAVE FLIPPED UP THE NECK. OVER THE WIRE EXCHANGE TO REPLACE THE PICC.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 199814 | POWERPICC SOLO HF CATHETER W/SHERLOCK 3CG (TPS) STYLET: | LJS | C. R. BARD INC. (BASD) | REXB0800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |