BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT 90

    MDR report key: 19328229 · Received May 16, 2024

    Report

    Report Number
    3003442380-2024-01877
    Event Type
    Malfunction
    Date Received
    May 16, 2024
    Report Date
    May 16, 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

    DEVICE 5 OF 5.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN SPAIN. IT WAS REPORTED THAT PATIENT FACED FIVE INFUSION SET CANNULA KINKED EVENTS ON 01-MAR-2024, 04-MAR-2024, 16-MAR-2024, 031-MAR-2024 AND 06-APR-2024 THE EVENTS OCCURRED WITHIN 3 HOURS OF INSERTION. THE INFUSION SET WAS IN USE FOR FEW HOURS. THE CUSTOMER REPLACED INFUSION SET AND RESUMED INSULIN DELIVERIES SUCCESSFULLY. 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 AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    475223 AUTOSOFT 90 UNO INSET II 60/6 GREY TCAP 10PK INT FPA 6000751 05705244018129

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown