BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIC-KEY

    MDR report key: 3890003 · Received June 11, 2014

    Report

    Report Number
    3890003
    Event Type
    Malfunction
    Date Received
    June 11, 2014
    Date of Event
    June 9, 2014
    Report Date
    June 11, 2014
    Manufacturer
    KIMBERLY-CLARK CORP
    Product Code
    KNT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    MIC-KEY PROCEDURE COMPLETED, PRIVATE RN THAT ACCOMPANIED THE PATIENT TO RADIOLOGY ATTEMPTED TO FEED THROUGH THE NEW TUBE, AND THE BALLOON WAS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    346111 MIC-KEY TUBE, GASTROINTESTINAL KNT KIMBERLY-CLARK CORP 0270-18-2.5-45 AA4078N28

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR