BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMT MINI ONE

    MDR report key: 9290314 · Received November 7, 2019

    Report

    Report Number
    9290314
    Event Type
    Malfunction
    Date Received
    November 7, 2019
    Date of Event
    May 17, 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 PRESENTED TO GASTROINTESTINAL CLINIC FOR ROUTINE VISIT. PATIENT'S PARENT NOTED ISSUE WITH CHECKING WATER IN AMT MINI ONE G-TUBE BALLOON. NURSE ASSESSED, UNABLE TO PULL ANY WATER OUT OF BALLOON OR INSTILL ANY WATER. VALVE OF BALLOON PORT NOTED TO BE BROKEN. TUBE HAD RECENTLY BEEN CHANGED OUT 1 MONTH AGO. PROVIDER CALLED INTO ROOM TO ASSESS, REQUIRING USE OF NEEDLE TO PUNCTURE STEM OF TUBE TO DRAIN WATER FROM BALLOON. THIS WAS SUCCESSFULLY COMPLETED, AND NEW TUBE WAS PLACED. THIS HAS BEEN AN ONGOING ISSUE WITH AMT TUBES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1087536 AMT MINI ONE TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT AMT -APPLIED MEDICAL TECHNOLOGY INC

    Patients

    Seq Age Sex Outcome Treatment
    1 730 DA