BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT 90

    MDR report key: 19473831 · Received June 5, 2024

    Report

    Report Number
    3003442380-2024-06217
    Event Type
    Malfunction
    Date Received
    June 5, 2024
    Date of Event
    February 19, 2024
    Report Date
    June 5, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244018129
    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 (B)(4). DEVICE 5 OF 10.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN SPAIN. IT WAS REPORTED THE PATIENT FACED A KINKED CANNULA ON 19-FEB-2024(2 EVENTS), 28-FEB-2024, 11-MAR-2024(2EVENTS), 23-MAR-2024, 07-APR-2024(2 EVENTS), 16-APR-2024, 28-APR-2024. THE ISSUE OCCURRED WITH TEN INFUSION SETS USED FOR A FEW HOURS. 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
    2055365 AUTOSOFT 90 UNO INSET II 60/6 GREY TCAP 10PK INT FPA UNOMEDICAL A/S 1002817 6000216 05705244018129

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female