BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSION DEVICES - UNKNOWN

    MDR report key: 20253893 · Received September 19, 2024

    Report

    Report Number
    3003442380-2024-25600
    Event Type
    Malfunction
    Date Received
    September 19, 2024
    Date of Event
    August 5, 2024
    Report Date
    August 20, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL AND FINAL MDR 1973620-DEVICE 3 OF 3.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. ON 05-AUG-2024, IT WAS REPORTED THAT THE PATIENT FACED INFUSION SET CANNULA WAS KINKED WITHIN 3 HOURS OF INSERTION AT ABDOMEN AND THIGH, WHICH CAUSE THE PATIENT BLOOD GLUCOSE LEVELS WAS ELEVATED TO 259MG/DL, THEREFORE PATIENT HAD RECEIVED CORRECTION INJECTION VIA MDI. THE PATIENT 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
    2527395 INFUSION DEVICES - UNKNOWN INFUSION DEVICES - UNKNOWN FPA UNOMEDICAL A/S UNKNOWN 6004839

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Female