FDA Adverse Event
Malfunction
Summary report: N
AUTOSOFT 90
MDR report key: 20319644
·
Received September 27, 2024
Report
- Report Number
- 3003442380-2024-27680
- Event Type
- Malfunction
- Date Received
- September 27, 2024
- Date of Event
- July 3, 2024
- Report Date
- August 30, 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 1992515 - MDR 3003442380-2024-27680 - DEVICE 3 OF 9. E1- PATIENT COUNTRY: SPAIN.
Description of Event or Problem · 0
REFERENCE NUMBER (B)(4). EVENT OCCURRED IN SPAIN. ON (B)(6) 2024, IT WAS REPORTED THAT THE PATIENT ENCOUNTERED 9 INFUSION SET CANNULA KINKED ISSUE 3 OR MORE HOURS AFTER INSERTION . THE SITE OF INSERTION WAS ABDOMEN . INFUSION SET HAS BEEN IN USE FOR 24 HOURS COMPANY DO NOT SEE BENT/KINKING AS BEING RELATED TO HUMAN FACTORS, BUT RATHER AS A TRAINING ISSUE INCLUDING CORRECT CHOICES OF INSERTION SITES AND INFUSION SETS AND CANNULA LENGTH. FURTHERMORE, THE SOFT CANNULA IS A FLEXIBLE MATERIAL THAT DURING USE AND UPON REMOVAL CAN BEND SLIGHTLY. NO FURTHER INFORMATION AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1433684 | AUTOSOFT 90 | UNO INSET II 60/6 GREY TCAP 10PK INT | FPA | UNOMEDICAL A/S | 1002817 | 6005316 | 05705244018129 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female |