FDA Adverse Event
Malfunction
Summary report: N
HENRY SCHEIN
MDR report key: 23159544
·
Received September 26, 2025
Report
- Report Number
- 3003674698-2025-01090
- Event Type
- Malfunction
- Date Received
- September 26, 2025
- Date of Event
- August 22, 2025
- Report Date
- September 26, 2025
- Manufacturer
- MEDSOURCE LABS LLC
- Product Code
- FOZ
- PMA / PMN Number
- K161779
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NV, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
THE SPRING TO RETRACT THE NEEDLE IS NOT WORKING PROPERLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2113182 | HENRY SCHEIN | HENRY SCHEIN SAFETY IV CATHETER 20G | FOZ | MEDSOURCE LABS LLC | 5702589 | 40709/0428 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |