FDA Adverse Event
Injury
Summary report: N
COOK INC
MDR report key: 360659
·
Received November 19, 2001
Report
- Report Number
- 360659
- Event Type
- Injury
- Date Received
- November 19, 2001
- Date of Event
- September 18, 2001
- Report Date
- October 12, 2001
- Manufacturer
- COOK, INC.
- Product Code
- DQO
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- OK, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
THE SMALL LUMEN END OF DEVICE (HUB TO CATHETER) CAME APART. THE CATHETER WAS REMOVED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 52352 | COOK INC | CENTRAL VENOUS CATHETER (DOUBLE LUMEN) | DQO | COOK, INC. | PICDS-601-MPIS | 1079081 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 87 YR | Required Intervention |