FDA Adverse Event
Malfunction
Summary report: N
MEDSOURCE
MDR report key: 22964460
·
Received September 4, 2025
Report
- Report Number
- 3003674698-2025-01060
- Event Type
- Malfunction
- Date Received
- September 4, 2025
- Date of Event
- August 7, 2025
- Report Date
- September 4, 2025
- Manufacturer
- MEDSOURCE LABS LLC
- Product Code
- FOZ
- UDI-DI
- 00816703020807
- PMA / PMN Number
- K161779
- 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
THE NEEDLE DID NOT FULLY RETRACT AFTER PRESSING BUTTON.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1851832 | MEDSOURCE | TRUESAFE SAFETY IV CATHETER 22G | FOZ | MEDSOURCE LABS LLC | MS-84422 | 30991/0623 | 00816703020807 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |