BEUDAMED
    FDA Adverse Event Death Summary report: N

    BARD NASOGASTRIC TUBE

    MDR report key: 1909985 · Received November 23, 2010

    Report

    Report Number
    1018233-2010-00145
    Event Type
    Death
    Date Received
    November 23, 2010
    Report Date
    October 29, 2010
    Manufacturer
    C.R. BARD, INC.
    Product Code
    KNT
    PMA / PMN Number
    PRE-AM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT SAMPLE, LOT NUMBER, AND INFORMATION REGARDING PLACEMENT OF THE PRODUCT COULD NOT BE OBTAINED SINCE THE USER FACILITY INFORMATION WAS NOT PROVIDED IN A MAUDE REPORT (B)(4). THE NG TUBE IS MADE OF PVC AND CONTAINS AN X-RAY RADIOPAQUE STRIPE FOR VERIFICATION OF PLACEMENT. A REVIEW OF DEVICE LABELING INDICATES THAT THE CURRENT INSTRUCTIONS FOR USE IMPLEMENTED IN MARCH 2009 STATES, "CONFIRM TUBE PLACEMENT PER HOSPITAL POLICY. THE TUBE HAS A RADIOPAQUE STRIPE FACILITATING X-RAY CONFIRMATION. IF PROPER PLACEMENT OF TUBE WITHIN THE STOMACH CANNOT BE CONFIRMED, REMOVE THE TUBE GENTLY AND START THE PROCEDURE AGAIN." THE PREVIOUS REVISION OF THE INSTRUCTIONS FOR USE (IMPLEMENTED IN AUGUST 2007) INDICATED, "TO CONFIRM PROPER PLACEMENT OF THE NASOGASTRIC SUMP TUBE PERFORM THE FOLLOWING: RAPIDLY INJECT APPROXIMATELY 10-20CC OF AIR THROUGH BLUE AIR VENT LUMEN WHILE AUSCULTATING THE ABDOMEN. THE RUSH OF AIR AS IT ENTERS THE STOMACH WILL BE HEARD IF THE TUBE IS CORRECTLY PLACED. ASPIRATE GENTLY TO OBTAIN STOMACH CONTENTS. X-RAYS MAY BE DONE TO CONFIRM TUBE PLACEMENT." THE PRODUCT LABELING PROVIDES ADEQUATE INSTRUCTIONS FOR PRODUCT PLACEMENT AND VERIFICATION BY X-RAY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSTRUCTIONS FOR USE DO NOT RECOMMEND X-RAY FOR PLACEMENT EVEN THOUGH, IT IS THE GOLD STANDARD. DEATH OF AN ADULT PT DUE TO MALPOSITION. ASPIRATION. NO ADDITIONAL INFORMATION COULD BE OBTAINED SINCE THE USER FACILITY INFORMATION WAS NOT PROVIDED IN MAUDE REPORT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD NASOGASTRIC TUBE KNT C.R. BARD, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death