BEUDAMED
    FDA Adverse Event Death Summary report: N

    NOVARTIS COMPAT

    MDR report key: 643923 · Received October 11, 2005

    Report

    Report Number
    MW1036880
    Event Type
    Death
    Date Received
    October 11, 2005
    Date of Event
    September 13, 2005
    Report Date
    October 11, 2005
    Manufacturer
    *
    Product Code
    FPD
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    TUBE FEEDING PLACED PER PROTOCOL BY 2 RN'S IN A CRITICALLY ILL PT, RESULTING IN PUNCTURE OF LUNG CAUSING PNEOMOTHORAX. THE TUBE IS A WEIGHTED TUBE WITH SYLETTER 42 INCHES IN LENGTH. IT IS DESIGNED TO PASS BEYOND THE PYLORIC SPHINCTER TO FACILITATE THE ASSIMILATION OF NUTRITION IN THE CRITICALLY ILL. IT HAS A WEIGHTED BOLUS OF 4 GRAMS TO REDUCE THE LIKELIHOOD OF MIGRATION. THE PT CODED AND RESPONDED POORLY TO RESUSCITATIVE EFFORTS. LATER A DECISION WAS MADE TO TERMINATE LIFE SUPPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOVARTIS COMPAT NASOGASTRIC FEEDING TUBE WITH STYLET 12 FRENCH FPD * 083105 *

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Death| R