FDA Adverse Event
Summary report: N
BARD ACCESS SYSTEMS, INC
MDR report key: 3066263
·
Received April 15, 2013
Report
- Report Number
- MW5029795
- Date Received
- April 15, 2013
- Date of Event
- March 28, 2012
- 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) 2011. RETURNED FOR BROKEN CLAMP (B)(6) 2012. REPLACED WITH VORTEX PORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 161805 | BARD ACCESS SYSTEMS, INC | HICKMAN, TRIFUSION | LJS | BARD ACCESS SYSTEM, INC | REVC0068 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 45 YR | Required Intervention |