FDA Adverse Event
Injury
Summary report: N
COOK SPECTRUM CENTRAL VENOUS TRAY
MDR report key: 2053028
·
Received April 8, 2011
Report
- Report Number
- MW5020226
- Event Type
- Injury
- Date Received
- April 8, 2011
- Date of Event
- February 28, 2001
- Report Date
- March 22, 2011
- Manufacturer
- COOK MEDICAL INC.
- Product Code
- FOZ
- Report Source
- Voluntary report
- Reporter Location
- DE, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
CENTRAL LINE PLACED. CHEST X-RAY REVEALED GUIDE WIRE EXTENDING FROM SUPERIOR VENA CAVA INTO RIGHT ATRIUM. GUIDE WIRE RETRIEVED IN INTERVENTIONAL RADIOLOGY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COOK SPECTRUM CENTRAL VENOUS TRAY | CENTRAL LINE | FOZ | COOK MEDICAL INC. | C-UTLMY-701J-CUSTOM-0005 | 2655895 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Required Intervention |