FDA Adverse Event
Malfunction
Summary report: N
AUTOSOFT 30
MDR report key: 19677355
·
Received July 4, 2024
Report
- Report Number
- 3003442380-2024-11496
- Event Type
- Malfunction
- Date Received
- July 4, 2024
- Date of Event
- February 8, 2024
- Report Date
- July 4, 2024
- Manufacturer
- UNOMEDICAL A/S
- Product Code
- FPA
- UDI-DI
- 05705244018365
- PMA / PMN Number
- K061374
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
INITIAL AND FINAL MDR (B)(4) - MDR DEVICE 3 OF 8.
Description of Event or Problem · 0
UNOMEDICAL REFERENCE NUMBER: (B)(4). EVENT OCCURRED IN (B)(6). IT WAS REPORTED THAT FROM PATIENT EXPERIENCED ISSUE WITH EIGHT INFUSION SETS AS THEY FELL OFF DURING USE. IT WAS STATED THAT EVENTS WERE OCCURRED ON VARIOUS DATES 08-FEB-2024, 22-FEB-2024, 15-MAR-2024, 31-MAR-2024, 11-MAR-2024, 30-APR-2024, 09-MAY-2024 AND 22-MAY-2024. NO FURTHER INFORMATION WAS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1133732 | AUTOSOFT 30 | UNO INSET 30 60/13 GREY TCAP 10PK INT | FPA | UNOMEDICAL A/S | 1002825 | UNKNOWN | 05705244018365 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 17 YR | Male |