BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

     AUTOSOFT 90

    MDR report key: 19841505 · Received July 26, 2024

    Report

    Report Number
    3003442380-2024-16596
    Event Type
    Malfunction
    Date Received
    July 26, 2024
    Date of Event
    June 16, 2024
    Report Date
    July 26, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    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 1922490 - MDR 3003442380-2024-16596- DEVICE 2 OF 4

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4) EVENT OCCURRED IN THE UNITED STATES ON (B)(6)2024, IT WAS REPORTED THAT THE PATIENT FACED FOUR KINKED CANNULA EVENT ON EVERY OTHER WEEK. THE EVENT OCCURRED AFTER THREE HOURS OF INSERTION. THE INFUSION SET WAS IN USE FOR 24 HOURS -3 DAYS. THE INFUSION SET WAS INSERTED IN ABDOMEN. BLOOD GLUCOSE LEVELS DURING THE EVENT WERE 200 MG/ML 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
    922782  AUTOSOFT 90  UNO INSET II 60/6 GREY TCAP 10PK INT FPA UNOMEDICAL A/S  1002817 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Female