FDA Adverse Event
Malfunction
Summary report: N
BARD ACCESS SYSTEM
MDR report key: 3080364
·
Received April 22, 2013
Report
- Report Number
- MW5029922
- Event Type
- Malfunction
- Date Received
- April 22, 2013
- Date of Event
- April 2, 2013
- Report Date
- April 22, 2013
- Manufacturer
- BARD ACCESS SYSTEMS
- Product Code
- LJS
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Description of Event or Problem · 1
PICC LINE FOUND TO BE LEAKING. WHEN EXAMINED FOUND SLIT IN PICC LINE CATHETER DISTAL TO INSERTION SITE. PICC WAS REMOVED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 173256 | BARD ACCESS SYSTEM | PICC | LJS | BARD ACCESS SYSTEMS | REXB0571 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 30 YR |