BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSION DEVICES - UNKNOWN - IDD

    MDR report key: 20454050 · Received October 15, 2024

    Report

    Report Number
    3003442380-2024-28270
    Event Type
    Malfunction
    Date Received
    October 15, 2024
    Date of Event
    September 9, 2024
    Report Date
    September 18, 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

    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 WILL 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 EXPERIENCED INFUSION SET'S BEING KINKED ON (B)(6) 2024. THIS ISSUE LED TO AN INCREASE IN BLOOD GLUCOSE LEVEL OF 400 MG/DL FOR WHICH TREATMENT OF INJECTION AND MULTIPLE DAILY INJECTIION WAS RECIEVED BY PATIENT. 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(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295240 INFUSION DEVICES - UNKNOWN - IDD INFUSION DEVICES - UNKNOWN FPA UNOMEDICAL A/S INFUSION DEVICES - UNKNOWN IDD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Female