FDA Adverse Event
Malfunction
Summary report: N
BROVIAC
MDR report key: 3779169
·
Received April 16, 2014
Report
- Report Number
- 3779169
- Event Type
- Malfunction
- Date Received
- April 16, 2014
- Date of Event
- April 8, 2014
- Report Date
- April 16, 2014
- Manufacturer
- BARD ACCESS SYSTEMS, INC
- Product Code
- LJS
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- CT, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
SURGICAL TECH REPORTED RESISTANCE AND THAT THE GLIDEWIRE DID NOT SLIDE SMOOTHLY WHILE PREPARING FOR HANDOFF TO THE SURGEON.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 233915 | BROVIAC | CATHETER | LJS | BARD ACCESS SYSTEMS, INC | * | HUWL0279 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 3 YR |