FDA Adverse Event
Injury
Summary report: N
BARD ACCESS SYSTEMS, INC
MDR report key: 3523177
·
Received December 12, 2013
Report
- Report Number
- MW5033447
- Event Type
- Injury
- Date Received
- December 12, 2013
- Date of Event
- November 27, 2013
- Report Date
- December 2, 2013
- Product Code
- LJS
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- MO, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
TRIFUSION CATHETER PLACED ON (B)(6) 2013. CATHETER FUNCTIONING NORMALLY, UNTIL (B)(6) 2013 WHEN THE ONE OF THE CLAMPS (THE RED ONE) BROKE. THE CATHETER WAS EXPECTED FOR A NEOSTAR ON (B)(6) 2013.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 649803 | BARD ACCESS SYSTEMS, INC | HICKMAN, TRIFUSION | LJS | REWJ0820 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Required Intervention |