FDA Adverse Event
Malfunction
Summary report: N
AUTOSOFT XC
MDR report key: 19490027
·
Received June 7, 2024
Report
- Report Number
- 3003442380-2024-06838
- Event Type
- Malfunction
- Date Received
- June 7, 2024
- Date of Event
- February 24, 2024
- Report Date
- June 7, 2024
- Manufacturer
- UNOMEDICAL A/S
- Product Code
- FPA
- UDI-DI
- 05705244016620
- 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 1881913 - DEVICE 4 OF 4.
Description of Event or Problem · 0
UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. ON 24 FEB 2024, IT WAS REPORTED THAT FOR INFUSION SETS CANNULA WERE KINKED AND EVENTS OCCURRED BETWEEN (B)(6) 2024 - (B)(6) 2024. THE SYMPTOMS WERE NOTICED THREE OR MORE HOURS AFTER INSERTION. THE INFUSION SET WAS INSERTED IN ABDOMEN AND THE INFUSION SET WAS IN USE FOR ROUGHLY THREE HOURS PER EVENT. UNOMEDICAL 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 |
|---|---|---|---|---|---|---|---|
| 1264982 | AUTOSOFT XC | UNO INSET I 60/6 GREY TCAP 10PK INT | FPA | UNOMEDICAL A/S | 1001680 | 6003399 | 05705244016620 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Male |