BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT 90

    MDR report key: 19685800 · Received July 6, 2024

    Report

    Report Number
    3003442380-2024-12434
    Event Type
    Malfunction
    Date Received
    July 6, 2024
    Date of Event
    May 3, 2024
    Report Date
    July 6, 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 (B)(4) - DEVICE 5 OF 6.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN SPAIN. ON 03-MAY-2024, 09-MAY-2024, 14-MAY-2024, 29-MAY-2024, 29-MAY-2024, AND 29-MAY-2024, IT WAS REPORTED THAT PATIENT FACED 6 INFUSION SET CANNULA KINKED EVENTS. THE EVENTS OCCURRED WITHIN 3 HOURS OF INSERTION. THE INFUSION SETS HAD BEEN USED FOR FEW HOURS. THE PATIENT REPLACED INFUSION SETS AND RESUMED INSULIN DELIVERIES SUCCESSFULLY. UNOMEDICAL DO NOT SEE 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 WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    930027 AUTOSOFT 90 UNO INSET II 60/6 GREY TCAP 10PK INT FPA UNOMEDICAL A/S 1002817 6004246 05705244018129

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown