BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT 90

    MDR report key: 19937228 · Received August 8, 2024

    Report

    Report Number
    3003442380-2024-19846
    Event Type
    Malfunction
    Date Received
    August 8, 2024
    Date of Event
    June 25, 2024
    Report Date
    July 9, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244018303
    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 1934111- MDR (B)(4) DEVICE 3 OF 5.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4) EVENT OCCURRED IN ITALY IT WAS REPORTED BY THE PATIENT'S INFUSION SET FELL OFF DURING USE ON (B)(6)2024. THE ISSUE OCCURRED WITH FIVE SIMILAR TYPES OF INFUSION SETS USED FOR MINIMUM 12 HOURS AND MAXIMUM ONE DAY. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1531792 AUTOSOFT 90 UNO INSET II 60/6 BLUE TCAP 10PK INT FPA UNOMEDICAL A/S 1002823 6002772 05705244018303

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown