BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFTÂ XC

    MDR report key: 20001284 · Received August 20, 2024

    Report

    Report Number
    3003442380-2024-21687
    Event Type
    Malfunction
    Date Received
    August 20, 2024
    Date of Event
    June 30, 2024
    Report Date
    July 18, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244026032
    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 1943338 - DEVICE 3 OF 3.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT PATIENT FACED 3 INFUSIONS SET CANNULA KINKED EVENT ON (B)(6) 2024 AFTER 3 HOURS OF INSERTION. INFUSION SET HAS BEEN USED FOR FEW HOURS. CUSTOMER CONFIRMED THE INTRODUCER NEEDLE WAS AHEAD OF THE CANNULA PRIOR TO INSERTION CUSTOMER REPLACED INFUSION SET AND RESUMED INSULIN DELIVERIES SUCCESSFULLY. 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
    1327141 AUTOSOFTÂ XC INSET I 2-PACK 60/9 GREY TCAP FPA UNOMEDICAL A/S 1010899 6005166 05705244026032

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Female