FDA Adverse Event
Malfunction
Summary report: N
IV SET, FLOW REG 92" 15M FIL IMS
MDR report key: 24821090
·
Received April 8, 2026
Report
- Report Number
- MW5186479
- Event Type
- Malfunction
- Date Received
- April 8, 2026
- Date of Event
- April 2, 2026
- Report Date
- April 3, 2026
- Manufacturer
- US INFUSION LLC. D/B/A TRUECARE BIOMEDIX-USA
- Product Code
- FPA
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- GA, US
- Reporter Occupation
- PHARMACIST
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
TUBING GOT PRIMED BUT WOULD NOT DRIP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 873489 | IV SET, FLOW REG 92" 15M FIL IMS | SET, ADMINISTRATION, INTRAVASCULAR | FPA | US INFUSION LLC. D/B/A TRUECARE BIOMEDIX-USA | 240785803 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female |