FDA Adverse Event
Malfunction
Summary report: N
IMED 8 IV EXT 12"
MDR report key: 23122398
·
Received September 22, 2025
Report
- Report Number
- MW5176360
- Event Type
- Malfunction
- Date Received
- September 22, 2025
- Date of Event
- September 11, 2025
- Report Date
- September 17, 2025
- Manufacturer
- UNK
- Product Code
- OJA
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
LEAK ON HER EXTENSION TUBING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 225482 | IMED 8 IV EXT 12" | INTRAVENOUS EXTENSION TUBING SET | OJA | UNK | 250317001 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female |