FDA Adverse Event
Malfunction
Summary report: N
AUTOSOFT 90
MDR report key: 19495166
·
Received June 9, 2024
Report
- Report Number
- 3003442380-2024-07343
- Event Type
- Malfunction
- Date Received
- June 9, 2024
- Date of Event
- May 4, 2024
- Report Date
- June 9, 2024
- Manufacturer
- UNOMEDICAL A/S
- Product Code
- FPA
- UDI-DI
- 05705244018129
- PMA / PMN Number
- K032854
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
INITIAL AND FINAL MDR 1883876- MDR 3003442380-2024-07343- DEVICE 1 OF 5.
Description of Event or Problem · 0
UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN SPAIN. IT WAS REPORTED THAT THE PATIENT'S INFUSION SET FELL OFF DURING USE 05-APR-2024, 18-APR-2024, 28-APR-2024, 30-APR-2024, 06-MAY-2024. THE ISSUE OCCURRED WITH FIVE INFUSION SET USED FOR FEW HOURS. NO FURTHER INFORMATION AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2326996 | AUTOSOFT 90 | UNO INSET II 60/6 GREY TCAP 10PK INT | FPA | UNOMEDICAL A/S | 1002817 | 5408438 | 05705244018129 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female |