FDA Adverse Event
Injury
Summary report: N
MCKESSON
MDR report key: 22169928
·
Received June 9, 2025
Report
- Report Number
- 3003674698-2025-00994
- Event Type
- Injury
- Date Received
- June 9, 2025
- Date of Event
- June 3, 2025
- Report Date
- June 9, 2025
- Manufacturer
- MEDSOURCE LABS LLC
- Product Code
- FOZ
- UDI-DI
- 10612479267487
- PMA / PMN Number
- K150611
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- 003
Narratives
Description of Event or Problem · 0
THE CATHETER WAS SEPARATED FROM THE BARREL POINT. THE CATHETER WAS BARELY OUT OF THE SKIN AND STILL IN THE VEIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1332862 | MCKESSON | MCKESSON SLIDE STYLE SAFETY IV CATHETER 20G X 1 | FOZ | MEDSOURCE LABS LLC | 200-IVS201 | 41049/0643 | 10612479267487 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other| H |