FDA Adverse Event
Malfunction
Summary report: N
ECLIPSE
MDR report key: 1222225
·
Received October 31, 2008
Report
- Report Number
- 1222225
- Event Type
- Malfunction
- Date Received
- October 31, 2008
- Date of Event
- October 29, 2008
- Report Date
- October 31, 2008
- Manufacturer
- BECTON DICKINSON
- Product Code
- FMI
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- SC, US
Narratives
Description of Event or Problem · 1
PHYSICIAN SUPPORT STAFF REPORTED HAVING THE SAME PROBLEM REPEATEDLY WITH THE BD ECLIPSE NEEDLE. THE PINK NEEDLE COVER IS BREAKING OFF, LEAVING THE STAFF AND PATIENTS AT RISK FOR A NEEDLE STICK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ECLIPSE | NEEDLE | FMI | BECTON DICKINSON | * | 2013-06 8171223 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |