FDA Adverse Event
Malfunction
Summary report: N
TRUESAFE
MDR report key: 22475096
·
Received July 10, 2025
Report
- Report Number
- 3003674698-2025-01013
- Event Type
- Malfunction
- Date Received
- July 10, 2025
- Date of Event
- June 13, 2025
- Report Date
- July 10, 2025
- Manufacturer
- MEDSOURCE LABS LLC
- Product Code
- FOZ
- UDI-DI
- 00816703020715
- PMA / PMN Number
- K161779
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
CATHETER DETACHED FROM HUB.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 894814 | TRUESAFE | TRUESAFE COMFORT SAFETY IV CATHETER 20G | FOZ | MEDSOURCE LABS LLC | MS-843202 | 41389/0875 | 00816703020715 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other| H |