FDA Adverse Event
Injury
Summary report: N
BARD ACCESS SYSTEMS, INC.
MDR report key: 3066330
·
Received April 15, 2013
Report
- Report Number
- MW5029809
- Event Type
- Injury
- Date Received
- April 15, 2013
- Date of Event
- December 14, 2011
- Report Date
- April 5, 2013
- Manufacturer
- BARD ACCESS SYSTEM, INC.
- Product Code
- DQO
- 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) 2011. REPLACED CATHETER. PATIENT PRESENTS TODAY FOR TRIFUSION CATHETER EXCHANGE SECONDARY TO BROKEN CLAMPS ON 2 OUT OF THE 3 HUBS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 161594 | BARD ACCESS SYSTEMS, INC. | HICKMAN, TRIFUSION | DQO | BARD ACCESS SYSTEM, INC. | REVE1099 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 31 YR | Required Intervention |