BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD MEDICAL NASOGASTRIC TUBE

    MDR report key: 5001447 · Received August 6, 2015

    Report

    Report Number
    MW5055354
    Event Type
    Malfunction
    Date Received
    August 6, 2015
    Date of Event
    July 21, 2015
    Report Date
    August 6, 2015
    Manufacturer
    BARD MEDICAL DIVISION
    Product Code
    KNT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    2

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2015, THE PT UNDERWENT TOTAL GASTRECTOMY FOR A NECROTIC STOMACH. AN NG WAS PLACED IN HIS LEFT NARES AT THAT TIME. ON (B)(6) 2015, THE PT WAS NOTED TO HAVE DEVELOPED A STAGE III LEFT NARES PRESSURE ULCER SECONDARY TO THE NG TUBE, WE HAVE NOTICED THAT THE BARD NG TUBES ARE STIFFER IN RECENT YEARS AND QUESTION WHETHER THIS MAY BE RELATED TO MOVEMENT TOWARDS BPA FREE PRODUCTS. THE NARES TISSUE IS QUITE FRIABLE AND CAN BREAKDOWN VERY QUICKLY WITH MINIMAL PRESSURE, SO THE STIFFER TUBE PLACES OUR PTS AT GREATER AND UNNECESSARY RISK. THE WOUND OSTOMY NURSE HAS COMMUNICATED HER CONCERNS TO THE PRODUCT REPRESENTATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    520875 BARD MEDICAL NASOGASTRIC TUBE NG TUBE KNT BARD MEDICAL DIVISION

    Patients

    Seq Age Sex Outcome Treatment
    1 100 YR Other