BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AUTOSOFT XC

    MDR report key: 19902585 · Received August 4, 2024

    Report

    Report Number
    3003442380-2024-18910
    Event Type
    Injury
    Date Received
    August 4, 2024
    Date of Event
    July 2, 2024
    Report Date
    July 5, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244026063
    PMA / PMN Number
    K032854
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL AND FINAL MDR 1931620 - MDR 3003442380-2024-18910 - DEVICE 2 OF 2

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES IT WAS REPORTED THAT THE PATIENT FACED TWO KINKED CANNULA EVENTS ON (B)(6)2024. DO NOT SEE KINKING AS BEING RELATED TO HUMAN FACTORS, BUT RATHER AS A TRAINING ISSUE INCLUDING CORRECT CHOICES OF INSERTION SITES AND INFUSION SETS AND CANNULA LENGTH. FURTHERMORE, THE SOFT CANNULA IS A FLEXIBLE MATERIAL THAT DURING USE AND UPON REMOVAL CAN BEND SLIGHTLY. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    951814 AUTOSOFT XC INSET I 2-PACK 12/6 GREY TCAP FPA UNOMEDICAL A/S 1009566 UNKNOWN 05705244026063

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Female Required Intervention