FDA Adverse Event
Malfunction
Summary report: N
PERCUTANEOUS IMPLANTED LONG TERM INTRAVASCULA
MDR report key: 2151244
·
Received June 21, 2011
Report
- Report Number
- 3006260740-2011-00189
- Event Type
- Malfunction
- Date Received
- June 21, 2011
- Report Date
- June 14, 2011
- Manufacturer
- C.R. BARD, INC. (BASD)
- Product Code
- LJS
- 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 FOR EVALUATION. A LOT HISTORY REVIEW (LHR) REVIEW IS NOT POSSIBLE, AS NO MANUFACTURING LOT NUMBER HAS BEEN PROVIDED BY THE COMPLAINANT.
Description of Event or Problem · 1
"PT TRANSFERRED WITH PICC LINE IN-SITU. DURING DRESSING CHANGE, INTRODUCER FOUND TO BE STILL IN LINE. X-RAY INDICATED RETAINED INTRODUCER AND WAS SUBSEQUENTLY REMOVED."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PERCUTANEOUS IMPLANTED LONG TERM INTRAVASCULA | PERCUTANEOUS IMPLANTED LONG TERM INTRAVASCULAR CATHETER | LJS | C.R. BARD, INC. (BASD) | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |