FDA Adverse Event
Malfunction
Summary report: N
BIOMEDIX
MDR report key: 22580388
·
Received July 23, 2025
Report
- Report Number
- 3003674698-2025-01025
- Event Type
- Malfunction
- Date Received
- July 23, 2025
- Date of Event
- July 9, 2025
- Report Date
- July 23, 2025
- Manufacturer
- MEDSOURCE LABS LLC
- Product Code
- FPA
- PMA / PMN Number
- K142097
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- 501
Narratives
Description of Event or Problem · 0
UNABLE TO ADMINISTER MEDICATION THROUGH THE LUER PORTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1717418 | BIOMEDIX | B74 SELEC-3 NIS LAS IV ADM SET | FPA | MEDSOURCE LABS LLC | B74-102 | B40806 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |