FDA Adverse Event
Other
Summary report: N
ARROW
MDR report key: 679459
·
Received January 26, 2006
Report
- Report Number
- 679459
- Event Type
- Other
- Date Received
- January 26, 2006
- Date of Event
- November 23, 2005
- Report Date
- December 2, 2005
- Manufacturer
- ARROW INTERNATIONAL, INC.
- Product Code
- DQO
- Report Source
- User Facility report
- Reporter Location
- CA, US
Narratives
Description of Event or Problem · 1
UPON WITHDRAWAL OF GUIDE WIRE DELIVERY PLACEMENT OF DOUBLE LUMEN CENTRAL VENOUS CATHETER THE WIRE BECAME UNRAVELED. THIS NECESSITATED REMOVAL OF THE CATHETER AND WIRE TO BE CERTAIN THE ENTIRE WIRE WAS REMOVED. ANOTHER KIT HAD TO BE USED. THE INTERNAL JUGULAR VEIN HAD TO BE STUCK AGAIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ARROW | KIT, CENTRAL VENOUS CATHETER | DQO | ARROW INTERNATIONAL, INC. | ARROW 7FR 16CM | RF5083280 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 41 YR |