BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 20341753 · Received October 1, 2024

    Report

    Report Number
    3003442380-2024-28137
    Event Type
    Injury
    Date Received
    October 1, 2024
    Date of Event
    August 23, 2024
    Report Date
    January 26, 2026
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    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 ON (B)(6) 2024 THAT THE PATIENT ADMITTED TO HOSPITAL (ICU) DUE TO BENT INFUSION SET CANNULA IN 3 OR MORE HOURS AFTER INSERTION WHICH LED TO HIGH BLOOD GLUCOSE LEVEL OVER 400MG/DL. THE INSERTION SITE WAS AT ABDOMEN. DURATION OF INFUSION SETS USED WAS 7 HOURS. THE PATIENT RECEIVED THE TREATMENT - IV AND FLUIDS OF SALINE AND INSULIN. THE PATIENT RELEASED FROM HOSPITAL ON (B)(6) 2024. THE TRACE KETONES WERE TESTED POSITIVE FOR THE 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40777 UNKNOWN INFUSION DEVICES - UNKNOWN FPA UNOMEDICAL A/S UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Male Required Intervention| H