BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINMED QUICK SET

    MDR report key: 19480305 · Received June 6, 2024

    Report

    Report Number
    3003442380-2024-06694
    Event Type
    Malfunction
    Date Received
    June 6, 2024
    Date of Event
    May 6, 2024
    Report Date
    June 7, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244017818
    PMA / PMN Number
    K160648
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL AND FINAL MDR 1881552 - MDR 3003442380-2024-06694 - DEVICE 1 OF 2. (B)(6).

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. ON (B)(6) 2024, IT WAS REPORTED THAT THE TWO INFUSION SET HAD BENT CANNULA. IT WAS LOCATED IN UPPER ABDOMEN. 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
    12494 MINMED QUICK SET UNO QUICK-SET 80/9 SC1 MECA FPA UNOMEDICAL A/S MMT-386A 6004585 05705244017818

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown