BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINMED QUICK SET

    MDR report key: 19399631 · Received May 27, 2024

    Report

    Report Number
    3003442380-2024-03720
    Event Type
    Malfunction
    Date Received
    May 27, 2024
    Date of Event
    April 18, 2024
    Report Date
    May 27, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244017573
    PMA / PMN Number
    K160648
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    MDR 1872712 - MDR (B)(4) DEVICE 1 OF 10 . PATIENT COUNTRY- (B)(6). PATIENT CITY-(B)(6).

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES ON (B)(6) 2024 PATIENT FACED INFUSION SET CANNUAL WAS BENT. SITE OF INSERTION OF CANNULA WAS ABDOMEN. INFUSION SET WAS IN USE FOR ONE DAY. PATIENT IS FACING ISSUE WITH QUICK SET INFUSION SET.PATIENT FACED THIS ISSUE WITH TEN INFUSION SETS. 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
    330668 MINMED QUICK SET UNO QUICK-SET 60/9 SC1 MECA FPA UNOMEDICAL A/S 6004802 05705244017573

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown