FDA Adverse Event
Malfunction
Summary report: N
4 FR SL POWERPICC SOLO CATHETER, BASIC
MDR report key: 3061608
·
Received April 11, 2013
Report
- Report Number
- 3006260740-2013-00152
- Event Type
- Malfunction
- Date Received
- April 11, 2013
- Report Date
- March 25, 2013
- Manufacturer
- C.R. BARD, INC. (BASD)
- Product Code
- LJS
- PMA / PMN Number
- K072230
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER AT THIS TIME FOR EVALUATION. A LOT HISTORY REVIEW (LHR) OF REWF0801 SHOWED TWO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.
Description of Event or Problem · 1
INTERNAL FRACTURE NOTED ON REMOVAL OF PICC AT APPROXIMATELY 30CM BELOW BIFURCATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 154479 | 4 FR SL POWERPICC SOLO CATHETER, BASIC | LJS | C.R. BARD, INC. (BASD) | REWF0801 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |