FDA Adverse Event
Malfunction
Summary report: N
SAFETY BLOOD COLLECTION SET AND HOLDER
MDR report key: 19682537
·
Received July 3, 2024
Report
- Report Number
- MW5157026
- Event Type
- Malfunction
- Date Received
- July 3, 2024
- Date of Event
- June 27, 2024
- Report Date
- June 28, 2024
- Manufacturer
- GREINER BIO-ONE NORTH AMERICA, INC.
- Product Code
- FMI
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- MO, US
- Reporter Occupation
- RISK MANAGER
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
WHEN THE SAFETY COVER WAS DEPLOYED, THE DEVICE BROKE APART.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 151400 | SAFETY BLOOD COLLECTION SET AND HOLDER | NEEDLE, HYPODERMIC, SINGLE LUMEN | FMI | GREINER BIO-ONE NORTH AMERICA, INC. | 450086 | 23128U |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |