FDA Adverse Event
Other
Summary report: N
BUNEGIN-ALBIN AIR ASPIRATION CVP CATHETER
MDR report key: 506213
·
Received January 13, 2004
Report
- Report Number
- 1820334-2004-00018
- Event Type
- Other
- Date Received
- January 13, 2004
- Date of Event
- June 1, 2003
- Report Date
- December 17, 2003
- Manufacturer
- COOK INC.
- Product Code
- DQO
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
THROMBUS OF MORE THAN 2CM IN DISTAL PART OF CATHETER. UNABLE TO ASPIRATE AIR DURING OPERATION, RESULTING IN AIR EMBOLIZATION. PT IN ICU FOR 3 DAYS. AT THIS TIME, PT IS DOING WELL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BUNEGIN-ALBIN AIR ASPIRATION CVP CATHETER | CATHETER | DQO | COOK INC. | NA | F1358718 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |