BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT 90

    MDR report key: 19848635 · Received July 28, 2024

    Report

    Report Number
    3003442380-2024-17662
    Event Type
    Malfunction
    Date Received
    July 28, 2024
    Date of Event
    June 21, 2024
    Report Date
    October 28, 2025
    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 1925118- MDR 3003442380-2024-17662 - DEVICE 1 OF 4.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN CANADA. IT WAS REPORTED THAT THE PATIENT FACED FOUR INFUSION SET NEEDLE WAS BROKE ON (B)(6) 2024. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400282 AUTOSOFT 90 UNO INSET II 60/9 GREY TCAP 10PK INT FPA UNOMEDICAL A/S 1002819 6005729

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Female