FDA Adverse Event
Injury
Summary report: N
CLEARSAFE
MDR report key: 22475097
·
Received July 10, 2025
Report
- Report Number
- 3003674698-2025-01008
- Event Type
- Injury
- Date Received
- July 10, 2025
- Date of Event
- June 11, 2025
- Report Date
- July 10, 2025
- Manufacturer
- MEDSOURCE LABS LLC
- Product Code
- FOZ
- UDI-DI
- 00816703020647
- PMA / PMN Number
- K150611
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- 003
Narratives
Description of Event or Problem · 0
THE PLASTIC CATHETER DETACHED INSIDE THE VEIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1049319 | CLEARSAFE | CLEARSAFE COMFORT 22G X 1IN | FOZ | MEDSOURCE LABS LLC | MS-84222 | 00816703020647 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Hospitalization| O |