BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUSTEEL

    MDR report key: 20166005 · Received September 8, 2024

    Report

    Report Number
    3003442380-2024-24470
    Event Type
    Malfunction
    Date Received
    September 8, 2024
    Date of Event
    April 10, 2024
    Report Date
    August 9, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244018426
    PMA / PMN Number
    K041545
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL AND FINAL MDR 1963769 - MDR 3003442380-2024-24470 - DEVICE 3 OF 3. H1: 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 PATIENT FACED 3 INFUSION SET INCORRECT INSERTION OF THE SOFT CANNULA ON (B)(6) 2024 AND THEN BLEEDING. THE FIRST TWO INFUSION SET WAS IN USE FOR MORE THAN 3 HOURS BUT LESS THAN 5 HOURS AND THIRD INFUSION SET WAS IN USE FOR ALMOST A FULL DAY. PATIENT REPLACED INFUSION SET AND RESUMED INSULIN DELIVERIES SUCCESSFULLY. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1319196 TRUSTEEL UNO CONTACT DETACH G29 60/6TCAP 10PK INT FPA UNOMEDICAL A/S 1002833 UNKNOWN 05705244018426

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Male