BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT 90

    MDR report key: 21050944 · Received January 1, 2025

    Report

    Report Number
    3003442380-2024-35397
    Event Type
    Malfunction
    Date Received
    January 1, 2025
    Date of Event
    November 25, 2024
    Report Date
    December 4, 2024
    Manufacturer
    UNOMEDICAL UM-D
    Product Code
    FPA
    UDI-DI
    05705244018129
    PMA / PMN Number
    K032854
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL AND FINAL MDR 2082630 - MDR - DEVICE 2 OF 2.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN SPAIN IT WAS REPORTED THAT THE PATIENT EXPERIENCED TWO EVENTS OF KINKED CANNULA ON 25-NOV-2024. PATIENT NOTICED SYMPTOMS WITHIN THREE HOURS OF INSERTION. THE SITE OF INSERTION WAS ABDOMEN. 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
    1254908 AUTOSOFT 90 UNO INSET II 60/6 GREY TCAP 10PK INT FPA UNOMEDICAL UM-D 1002817 6006131 05705244018129

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown