FDA Adverse Event
Malfunction
Summary report: N
CROSSER
MDR report key: 3192331
·
Received June 26, 2013
Report
- Report Number
- 3192331
- Event Type
- Malfunction
- Date Received
- June 26, 2013
- Date of Event
- June 3, 2013
- Report Date
- June 26, 2013
- Manufacturer
- BARD PERIPHERAL VASCULAR, INC. ,
- Product Code
- DQY
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- RI, US
Narratives
Description of Event or Problem · 1
DURING ANGIOGRAPHIC PROCEDURE CATHETER TIP WAS BROKEN OFF IN PATIENT.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 291406 | CROSSER | CATHETER | DQY | BARD PERIPHERAL VASCULAR, INC. , | CRUS6A | FCXC10011 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR |