FDA Adverse Event
Malfunction
Summary report: N
YUEH CENTESIS DISPOSABLE CATHETER NEEDLE
MDR report key: 12770230
·
Received November 8, 2021
Report
- Report Number
- 12770230
- Event Type
- Malfunction
- Date Received
- November 8, 2021
- Date of Event
- October 23, 2021
- Report Date
- November 1, 2021
- Manufacturer
- COOK INCORPORATED
- Product Code
- GCB
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- FL
- Reporter Occupation
- RISK MANAGER
- Health Professional
- N
Narratives
Description of Event or Problem · 0
PHYSICIAN WAS REMOVING THE HEAD OF THE YUEH NEEDLE, AND THE HEAD OF IT BROKE OFF.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1672564 | YUEH CENTESIS DISPOSABLE CATHETER NEEDLE | NEEDLE, CATHETER | GCB | COOK INCORPORATED | G09489 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 20075 DA | Male |