FDA Adverse Event
Malfunction
Summary report: N
BROVIAC 4.2 FR SL CVC PEEL-APART INTRO KIT W/TISSUE INGROWTH
MDR report key: 3874602
·
Received April 24, 2014
Report
- Report Number
- 3006260740-2014-00210
- Event Type
- Malfunction
- Date Received
- April 24, 2014
- Date of Event
- March 13, 2014
- Report Date
- April 1, 2014
- Manufacturer
- C.R. BARD, INC. (BASD)
- Product Code
- LJS
- PMA / PMN Number
- K830256
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BE
- Reporter Occupation
- PHARMACIST
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER, AT THIS TIME, FOR EVALUATION. A LOT HISTORY REVIEW (LHR) OF HUXG1673 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.
Description of Event or Problem · 1
IT WAS REPORTED THAT A LEAK WAS NOTED. PRODUCT HAD TO BE REMOVED. LEAKAGE WAS AT THE INSIDE OF THE PATIENT. CATHETER WAS REPLACED. REPLACEMENT RESULTED IN LONGER STAY IN THE HOSPITAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 248151 | BROVIAC 4.2 FR SL CVC PEEL-APART INTRO KIT W/TISSUE INGROWTH | LJS | C.R. BARD, INC. (BASD) | HUXG1673 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |