BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUSTEEL

    MDR report key: 12947981 · Received December 7, 2021

    Report

    Report Number
    3003442380-2021-00786
    Event Type
    Malfunction
    Date Received
    December 7, 2021
    Report Date
    December 7, 2021
    Product Code
    FPA
    UDI-DI
    05705244018518
    PMA / PMN Number
    K041545
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT'S INFUSION SET'S TUBING DETACHED/BROKEN AT SITE CONNECTOR MULTIPLE TIMES. AT THE TIME OF THE EVENT, HIS BLOOD GLUCOSE LEVEL WAS 241-300 MG/DL. THE INFUSION SET HAD BEEN USED FOR TWENTY-FOUR HOURS. FURTHER, THEY REPLACED THE INFUSION SET AND INSULIN WAS RESUMED SUCCESSFULLY. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1852496 TRUSTEEL UNO CONTACT DETACH G29 80/8TCAP 10PK INT FPA 1002836 5345351 05705244018518

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown