FDA Adverse Event
Malfunction
Summary report: N
INFUSION DEVICES - UNKNOWN
MDR report key: 19772095
·
Received July 18, 2024
Report
- Report Number
- 3003442380-2024-15078
- Event Type
- Malfunction
- Date Received
- July 18, 2024
- Date of Event
- June 10, 2024
- Report Date
- July 18, 2024
- Manufacturer
- UNOMEDICAL A/S
- Product Code
- FPA
- PMA / PMN Number
- UNKNOWN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- 003
Narratives
Description of Event or Problem · 0
UNOMEDICAL REFERENCE NUMBER (B)(6). EVENT OCCURRED IN FRANCE. IT WAS REPORTED THAT, THE PATIENT HAD SEVERAL INFUSIONS SETS THAT WERE LEAKED. THE EVENT OCCURRED ON 10-JUN-2024. NO FURTHER INFORMATION AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1556487 | INFUSION DEVICES - UNKNOWN | INFUSION DEVICES - UNKNOWN | FPA | UNOMEDICAL A/S | UNKNOWN | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 34 YR | Female |