FDA Adverse Event
Other
Summary report: N
COOK CRITICAL CARE/DIV. COOK INC.
MDR report key: 389241
·
Received June 26, 2002
Report
- Report Number
- 389241
- Event Type
- Other
- Date Received
- June 26, 2002
- Date of Event
- February 28, 2002
- Report Date
- March 5, 2002
- Manufacturer
- COOK INC.
- Product Code
- DQO
- Adverse Event
- Yes
- Report Source
- User Facility report
- Reporter Location
- KY, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
DURING ATTEMPT TO INSERT CENTRAL LINE, DIFFICULTY WAS ENCOUNTERED WHEN REMOVING THE GUIDE WIRE. UPON REMOVAL OF THE GUIDE WIRE IT SHREDDED APART. STAFF WERE UNABLE TO DETERMINE IF ALL PIECES WERE ATTACHED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COOK CRITICAL CARE/DIV. COOK INC. | CENTRAL VENOUS CATHETERS | DQO | COOK INC. | REORDER# C-PMS-500 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR | Other |