BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUSTEEL

    MDR report key: 19421702 · Received May 29, 2024

    Report

    Report Number
    3003442380-2024-04281
    Event Type
    Malfunction
    Date Received
    May 29, 2024
    Date of Event
    February 1, 2024
    Report Date
    May 29, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    PMA / PMN Number
    K041545
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE 2 OF 10.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES IT WAS REPORTED THAT TEN INFUSION SETS CANNULA WERE BENT. THE EVENT DATES WERE BETWEEN 01 FEBRUARY 2024 AND 13 APRIL 2024. PATIENT'S BLOOD GLUCOSE LEVEL WAS BETWEEN 200-401 MG/DL. WITHIN 3 HOURS OF INSERTION CUSTOMER NOTICED SYMPTOMS. CUSTOMER REPLACED INFUSION SET AND RESUMED INSULIN DELIVERIES SUCCESSFULLY. UNOMEDICAL 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
    1286276 TRUSTEEL UNO CONTACT DETACH G29 60/6TCAP 10PK INT FPA UNOMEDICAL A/S UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Male