BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT 90

    MDR report key: 21195422 · Received January 21, 2025

    Report

    Report Number
    3003442380-2024-37589
    Event Type
    Malfunction
    Date Received
    January 21, 2025
    Date of Event
    October 31, 2024
    Report Date
    December 31, 2024
    Manufacturer
    UNOMEDICAL UM-D
    Product Code
    FPA
    UDI-DI
    05705244018181
    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 2102600 - MDR 3003442380-2024-37589- DEVICE 1 OF 4.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN CANADA. IT WAS REPORTED THAT PATIENT FACED FOUR INFUSION SETS CANNULA KINKED. THESE EVENTS OCCURRED BETWEEN 31-OCT-2024 AND 25-DEC-2024. THESE EVENTS OCCURRED AFTER THREE OR MORE HOURS OF INSERTION. INSERTION SITE WAS ABDOMEN. INFUSION SET HAD BEEN USED FOR TWO TO SEVEN HOURS. A CUSTOMER REPLACED INFUSION SET AND RESUMED INSULIN DELIVERIES SUCCESSFULLY. 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
    741457 AUTOSOFT 90 UNO INSET II 60/9 GREY TCAP 10PK INT FPA UNOMEDICAL UM-D 1002819 6008161 05705244018181

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male