BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT XC

    MDR report key: 19936601 · Received August 8, 2024

    Report

    Report Number
    3003442380-2024-19572
    Event Type
    Malfunction
    Date Received
    August 8, 2024
    Date of Event
    June 10, 2024
    Report Date
    July 9, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244016620
    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 1934002 - MDR 3003442380-2024-19572 - DEVICE 4 OF 8.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT PATIENT FACED EIGHT INFUSION SETS CANNULA KINKED EVENTS ON 10-JUN-2024. ALL THE EVENTS OCCURRED WITHIN 3 HOURS OF INSERTION AND THE INSERTION SITE WAS AT ABDOMEN AND THIGH. COMPANY DO NOT SEE BENT/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 AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2398759 AUTOSOFT XC UNO INSET I 60/6 GREY TCAP 10PK INT FPA UNOMEDICAL A/S 1001680 6003726 05705244016620

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Male