BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT 90

    MDR report key: 20093973 · Received August 29, 2024

    Report

    Report Number
    3003442380-2024-22977
    Event Type
    Malfunction
    Date Received
    August 29, 2024
    Date of Event
    June 26, 2024
    Report Date
    July 30, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    PMA / PMN Number
    K032854
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL AND FINAL MDR 1953645- MDR 3003442380-2024-22977- DEVICE 4 OF 15.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT FACED LEAKAGE OF TUBING AT SITE. THE ISSUE OCCURRED WITH FIFTEEN TYPES OF INFUSION SETS USED FOR LESS THAN A DAY. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1158891 AUTOSOFT 90 UNO INSET II 60/9 BLUE TCAP 10PK INT FPA UNOMEDICAL A/S 1002824 6001900

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Male