BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMT MINI ONE

    MDR report key: 9290260 · Received November 7, 2019

    Report

    Report Number
    9290260
    Event Type
    Malfunction
    Date Received
    November 7, 2019
    Date of Event
    July 25, 2019
    Report Date
    November 1, 2019
    Manufacturer
    AMT APPLIED MEDICAL TECHNOLOGY INC
    Product Code
    KNT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PATIENT IN ONCOLOGY, PROVIDER CALLED TO REPORT GTUBE NOT ACCOMMODATING THE EXTENSION. PATIENT CAME TO GASTROINTESTINAL ASSESSMENT. TUBE WAS CHANGED AS THE OUTER DISK THAT ENABLES THE TUBE TO LOCK TO THE EXTENSION WAS MISSING. IT APPEARS THAT THE OUTSIDE DISC WHICH IS NOTCHED TO ALLOW THE EXTENSION TO BE LOCKED IN PLACE IS MISSING EVERY 8 HOURS. IT WAS DECIDED TO CHANGE THE TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1086445 AMT MINI ONE TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT AMT APPLIED MEDICAL TECHNOLOGY INC

    Patients

    Seq Age Sex Outcome Treatment
    1 1095 DA