BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSION DEVICES - UNKNOWN

    MDR report key: 20459977 · Received October 16, 2024

    Report

    Report Number
    3003442380-2024-28575
    Event Type
    Malfunction
    Date Received
    October 16, 2024
    Date of Event
    July 20, 2024
    Report Date
    September 19, 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 2012960 - MDR 3003442380-2024-28575 - DEVICE 4 OF 4. H11: SINCE NO LOT NUMBER IS AVAILABLE, A DETAILED INVESTIGATION, TESTS ON REFERENCE SAMPLES OR BATCH REVIEW CANNOT BE CONDUCTED. THEREFORE, THIS COMPLAINT WILL BE CLOSED, THIS ISSUE WILL BE MONITORED THROUGH PMS PRODUCT TRENDS AND MALFUNCTION. IF ANY TRENDS PICKED UP, THIS WOULD FLAG ON THE TRIPS AND ALERTS ACCORDING TO THE OMQR PROCEDURE.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT FACED FOUR INFUSION SET CANNULA KINKED EVENTS, THE FIRST ON (B)(6) 2024 AND THE REMAINING THREE APPROXIMATELY TWO WEEKS LATER. THE EVENTS OCCURRED WITHIN 3 OR MORE HOURS OF INSERTION. THE INFUSION SETS HAD BEEN USED FOR 36 HOURS. THE INSERTION SITE WAS AT THE THIGH. THE BLOOD GLUCOSE LEVEL WAS 450 MG/DL AT THE TIME OF THE EVENTS; THEREFORE, IT WAS TREATED WITH CORRECTION INJECTIONS VIA MULTIPLE DAILY INJECTIONS (MDI). THE PATIENT REPLACED THE INFUSION SETS AND RESUMED INSULIN DELIVERIES SUCCESSFULLY. COMPANY 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
    2558785 INFUSION DEVICES - UNKNOWN INFUSION DEVICES - UNKNOWN FPA UNOMEDICAL A/S UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Female