BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT 90

    MDR report key: 19902157 · Received August 3, 2024

    Report

    Report Number
    3003442380-2024-18882
    Event Type
    Malfunction
    Date Received
    August 3, 2024
    Date of Event
    June 12, 2024
    Report Date
    July 5, 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 1931205 (B)(4).

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN AUSTRALIA. IT WAS REPORTED THAT PATIENT FACED SIX INFUSION SETS CANNULA KINKED EVENTS ON 12-JUN-2024. THE PATIENT NOTICED SYMPTOMS WITHIN THREE HOURS AFTER INSERTION. INSERTION SITE WAS ABDOMEN. PATIENT REGULARLY ROTATED SITE LOCATION. PATIENT CONFIRMED THE INTRODUCER NEEDLE WAS AHEAD OF THE CANNULA PRIOR TO INSERTION. THEREFORE, PATIENT REPLACED INFUSION SET AND RESUMED INSULIN SUCCESSFULLY. 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 WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    951677 AUTOSOFT 90 UNO INSET II 60/6 GREY TCAP 10PK INT FPA UNOMEDICAL A/S 1002817 6003469 05705244018129

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown