FDA Adverse Event
Summary report: N
BARD ACCESS SYSTEMS, INC
MDR report key: 3066258
·
Received April 15, 2013
Report
- Report Number
- MW5029792
- Date Received
- April 15, 2013
- Date of Event
- October 10, 2011
- 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) 2010. REMOVAL FOR A BROKEN CLAMP (B)(6) 2011. BROKEN CLAMP, PT CHOSE TO HAVE IT REPLACED, THEREBY FOREGOING PHOTOPHERESIS TREATMENTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 160430 | BARD ACCESS SYSTEMS, INC | HICKMAN, TRIFUSION | LJS | BARD ACCESS SYSTEM, INC | REUA0410 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Required Intervention |