FDA Adverse Event
Malfunction
Summary report: N
SPECTRUM CENTRAL VENOUS CATHETER SET
MDR report key: 3200863
·
Received June 21, 2013
Report
- Report Number
- 3200863
- Event Type
- Malfunction
- Date Received
- June 21, 2013
- Date of Event
- June 20, 2013
- Report Date
- June 21, 2013
- Manufacturer
- COOK MEDICAL
- Product Code
- FOZ
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- MI, US
- Reporter Occupation
- RISK MANAGER
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 282362 | SPECTRUM CENTRAL VENOUS CATHETER SET | CATHETER, INTRAVASCULAR, DIAGNOSTIC, CENTRAL VENOUS | FOZ | COOK MEDICAL | * | C-UDM-4015-ABRM |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 8 YR |