BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSET, INSET II, T:90

    MDR report key: 19947631 · Received August 9, 2024

    Report

    Report Number
    3003442380-2024-20327
    Event Type
    Malfunction
    Date Received
    August 9, 2024
    Date of Event
    June 15, 2024
    Report Date
    July 10, 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 1935413 - MDR 3003442380-2024-20327 - DEVICE 2 OF 3.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. ON 15-JUN-2024 AND 16-JUN-2024, IT WAS REPORTED THAT THE PATIENT FACED THREE INFUSION SETS KINKED CANNULA WITHIN 3 OR MORE HOURS OF INSERTION. SITE OF INSERTION WAS THIGH. INFUSION SETS WERE IN USE FOR 6-8 HOURS. PATIENT'S BLOOD GLUCOSE AT THE TIME OF ISSUE WAS REPORTED AS HIGH. THE PATIENT REPLACED INFUSION SETS AND RESUMED INSULIN 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
    1646616 INSET, INSET II, T:90 INSET I 2-PACK 60/9 GREY TCAP FPA UNOMEDICAL A/S 1010899 6004394 05705244026032

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Male