FDA Adverse Event
Injury
Summary report: N
BARD ACCESS SYSTEM, INC.
MDR report key: 3066294
·
Received April 15, 2013
Report
- Report Number
- MW5029802
- Event Type
- Injury
- Date Received
- April 15, 2013
- Date of Event
- February 6, 2009
- Report Date
- April 5, 2013
- Manufacturer
- BARD ACCESS SYSTEM, INC.
- Product Code
- LJS
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- MO, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
TRIFUSION PLACEMENT (B)(6) 2008. RETURNED FOR MALFUNCTION (B)(6) 2009. REPLACED CATHETER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 160708 | BARD ACCESS SYSTEM, INC. | HICKMAN, TRIFUSION | LJS | BARD ACCESS SYSTEM, INC. | * | RESF0150 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 30 YR | Required Intervention |