BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIO¿ ADVANCE

    MDR report key: 19482139 · Received June 7, 2024

    Report

    Report Number
    8021545-2024-00869
    Event Type
    Malfunction
    Date Received
    June 7, 2024
    Date of Event
    April 30, 2024
    Report Date
    June 7, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244019089
    PMA / PMN Number
    K173879
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL AND FINAL MDR 1881692- MDR 8021545-2024-00869- DEVICE 1 OF 3. E1: PATIENT CITY: (B)(6). PATIENT COUNTRY: UNITED STATES.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. ON (B)(6) 2024, IT WAS REPORTED BY THE PATIENT MOTHER THAT THREE INFUSION SET CANNULA WAS FOUND BENT. ONE DUE TO BLEEDING AND BENT CANNULA AND ANOTHER ONE IS DUE TO TUBING DETACHED AND BENT CANNULA. INFUSION SET WAS PLACED IN 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 WAS AVAILABLE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1259365 MIO¿ ADVANCE UNO MIO ADV. GREY 110/6 SC1 10-PK INT FPA UNOMEDICAL A/S MMT-213A 6004078 05705244019089

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female