FDA Adverse Event
Malfunction
Summary report: N
BROVIAC 4.2 FR S/L CATHETER
MDR report key: 1022312
·
Received March 31, 2008
Report
- Report Number
- 2523003-2008-00015
- Event Type
- Malfunction
- Date Received
- March 31, 2008
- Date of Event
- January 30, 2008
- Report Date
- March 3, 2008
- Manufacturer
- C.R. BARD, INC. (BASD)
- Product Code
- LJS
- PMA / PMN Number
- K830256
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE MFR HAS RECEIVED THE SAMPLE AND WILL BE EVALUATED. RESULTS ARE EXPECTED SOON.
Description of Event or Problem · 1
A BREAK IN THE CATHETER. FOUND A BLOOD LEAKAGE AT THE DISTAL END OF THE CATHETER DURING ASPIRATION. THE DEVICE HAD BEEN IN PLACE FOR 49 DAYS PRIOR TO THE INCIDENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BROVIAC 4.2 FR S/L CATHETER | LJS | C.R. BARD, INC. (BASD) | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |