FDA Adverse Event
Malfunction
Summary report: N
VANTEX CENTRAL VENOUS CATHETER WITH OLIGON MATERIAL WITH OR WITHOUT AMC THROMBOS
MDR report key: 1220805
·
Received October 30, 2008
Report
- Report Number
- 6000002-2008-09128
- Event Type
- Malfunction
- Date Received
- October 30, 2008
- Date of Event
- October 1, 2008
- Report Date
- October 1, 2008
- Manufacturer
- EDWARDS LIFESCIENCES, PR
- Product Code
- DQO
- PMA / PMN Number
- K992532
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
METHOD - THE ACTUAL DEVICE WILL NOT BE RETURNED; HOWEVER, A TEST SAMPLE FROM THE WAREHOUSE MAY BE RETURNED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THERE ARE LENGTH INDICATOR MARKED BY WHITE SPOTS ON THE CATHETER, AND OUR CUSTOMER SAID THAT IT EASILY WAS TAKEN OFF DURING INSERTION OF THE CATHETER. IT WAS CHECKED AND IT WAS REMOVED EASILY WITH A FINGERNAIL. IT WAS FURTHER REPORTED THAT THE CUSTOMER WAS CONCERNED ABOUT SAFETY OF THE WHITE MATERIAL, AND THEY SAID IT HAS NEVER HAPPENED IN OTHER CATHETERS. NO PT COMPLICATIONS WERE REPORTED. DEVICE WILL NOT BE RETURNED FOR EVALUATION; HOWEVER, A TEST SAMPLE MAY BE RETURNED. MODEL NUMBER WAS NOT REPORTED; HOWEVER, IT WAS STATED THAT IT WAS A VANTEX CATHETER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VANTEX CENTRAL VENOUS CATHETER WITH OLIGON MATERIAL WITH OR WITHOUT AMC THROMBOS | VANTEX CENTRAL VENOUS CATHETER | DQO | EDWARDS LIFESCIENCES, PR | CCUNKNOWN | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |