BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT 90

    MDR report key: 19327694 · Received May 15, 2024

    Report

    Report Number
    3003442380-2024-01972
    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 3003442380-2024-01972- DEVICE 4 OF 5.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN SPAIN. ON (B)(6) 2024, IT WAS REPORTED BY THE PATIENT FOR THE KINKED CANNULA WITHIN FEW HOURS OF USE. EVENT WAS OCCURRED ON 03/03/2024, 15/03/2024, 18/03/2024, 23/03/2024, AND 28/03/2024. 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
    924843 AUTOSOFT 90 UNO INSET II 60/6 GREY TCAP 10PK INT FPA 6002617 05705244018129

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown