FDA Adverse Event
Malfunction
Summary report: N
HENRY SCHEIN
MDR report key: 23115993
·
Received September 22, 2025
Report
- Report Number
- 3003674698-2025-01088
- Event Type
- Malfunction
- Date Received
- September 22, 2025
- Date of Event
- August 21, 2025
- Report Date
- September 22, 2025
- Manufacturer
- MEDSOURCE LABS LLC
- Product Code
- FOZ
- PMA / PMN Number
- K223788
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
NEEDLE IS NOT RETRACTING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 733602 | HENRY SCHEIN | HENRY SCHEIN PUSH BUTTON BC SAFETY IV CATHETER 24G | FOZ | MEDSOURCE LABS LLC | 5703716 | 40474/0295 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |