FDA Adverse Event
Malfunction
Summary report: N
MULTI-MED CENTRAL VENOUS CATHETER SET WITH AMC THROMBOSHIELD
MDR report key: 1162282
·
Received September 5, 2008
Report
- Report Number
- 6000002-2008-08611
- Event Type
- Malfunction
- Date Received
- September 5, 2008
- Date of Event
- June 6, 2008
- Report Date
- August 8, 2008
- Manufacturer
- EDWARDS LIFESCIECES, PR
- Product Code
- DQO
- PMA / PMN Number
- K955839
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
DEVICE WILL NOT BE RETURNED FOR EVALUATION.
Description of Event or Problem · 1
THE GUIDE LINE SHOWED A TWICE RUPTURE. THE PRODUCT WILL NOT BE RETURNED FOR EVALUATION. FOLLOWED UP WITH CUSTOMER, INDICATED THAT THE GUIDE LINE (GUIDE WIRE) WAS BREAKING IN TWO, DISRUPTION, RUPTURE = DISRUPTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MULTI-MED CENTRAL VENOUS CATHETER SET WITH AMC THROMBOSHIELD | CENTRAL VENOUS CATHETER | DQO | EDWARDS LIFESCIECES, PR | M2720HE | 58458201 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |