BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT 90

    MDR report key: 19327584 · Received May 15, 2024

    Report

    Report Number
    3003442380-2024-01946
    Event Type
    Malfunction
    Date Received
    May 15, 2024
    Report Date
    May 15, 2024
    Product Code
    FPA
    UDI-DI
    05705244018129
    PMA / PMN Number
    K032854
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    MDR 3003442380-2024-01946- DEVICE 3 OF 5.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN SPAIN ON 11-APRIL-2024, IT WAS REPORTED BY THE PATIENT FOR THE KINKED CANNULA WITHIN FEW HOURS OF USE. EVENT WAS OCCURRED ON 10/03/2024, 15/03/2024, 20/03/2024, 25/03/2024, AND 29/03/2024. 5 INFUSION SET WAS AFFECTED. UNOMEDICAL 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 WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667984 AUTOSOFT 90 UNO INSET II 60/6 GREY TCAP 10PK INT FPA 5397989 05705244018129

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown