BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIONE

    MDR report key: 10501724 · Received September 8, 2020

    Report

    Report Number
    10501724
    Event Type
    Malfunction
    Date Received
    September 8, 2020
    Date of Event
    August 8, 2020
    Report Date
    August 27, 2020
    Manufacturer
    APPLIED MEDICAL TECHNOLOGY, INC.
    Product Code
    KNT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    WHILE HOLDING INFANT, MOTHER NOTICED WARM AND WET SPOT IN INFANT'S ABDOMEN. MOTHER PLACED INFANT BACK TO CRIB AND NOTIFIED BEDSIDE RN. RN FOUND THAT G-TUBE HAD COME OUT OF PATIENT. PEDI-SURG TEAM ARRIVED AT 0815 TO PLACE NEW ENFIT 14 FR G-TUBE AND INFLATED BALLOON TO 4ML. FORMER G-TUBE EXAMINED AND OBSERVED BALLOON BURST. WE HAVE AT LEAST 8 SIMILAR EVENTS OVER THE PAST 6 MONTHS WHERE THE BALLOON HAS RUPTURED, CAUSING THE TUBE TO FALL OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    966691 MINIONE TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT APPLIED MEDICAL TECHNOLOGY, INC. MINIONE BALLOON BUTTON 14FR

    Patients

    Seq Age Sex Outcome Treatment
    1 60 DA