BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDICAL ACTION INDUSTRIES

    MDR report key: 9165655 · Received October 8, 2019

    Report

    Report Number
    9165655
    Event Type
    Malfunction
    Date Received
    October 8, 2019
    Date of Event
    September 13, 2019
    Report Date
    September 24, 2019
    Manufacturer
    MEDICAL ACTION INDUSTRIES INC.
    Product Code
    NXA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    TRACH CARE TRAY OPENED AT BEDSIDE TO FIND THAT THE SALINE CONTAINER WAS EMPTY AND THERE IS BROWN/YELLOW COLORED, DRIED FLUID ALL OVER THE INSIDE CONTENTS. TRAY COMPLETELY UNUSABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    959520 MEDICAL ACTION INDUSTRIES TRACHEOTOMY CARE KIT NXA MEDICAL ACTION INDUSTRIES INC. 75378 259371

    Patients

    Seq Age Sex Outcome Treatment
    1