BEUDAMED
    FDA Adverse Event Summary report: N

    NEOBAR

    MDR report key: 2435057 · Received January 25, 2012

    Report

    Report Number
    2435057
    Date Received
    January 25, 2012
    Date of Event
    January 24, 2012
    Report Date
    January 25, 2012
    Manufacturer
    NEOTECH PRODUCTS, INC
    Product Code
    CBH
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    THIS IS AT LEAST THE 6TH INCIDENT WITH NEOBAR IN WHICH THE TAB OF THE STABILIZATION PLATFORM SEPARATED FROM THE ADHESIVE CAUSING EXTUBATION OF THE ORAL ETT. THE INFANT REQUIRED REINTUBATION. THIS PRODUCT HAS BEEN USED AT OUR FACILITY FOR OVER FIVE YEARS AND THERE WERE NO PROBLEMS UNTIL LAST YEAR (2011). WE HAVE HAD MULTIPLE INFANTS EXTUBATED IN THE SAME MANNER. THIS IS A VERY SERIOUS ISSUE AND COULD POTENTIALLY CAUSE GREAT HARM. WE ARE UNABLE TO IDENTIFY A SPECIFIC COLOR (NUMBERED) OR LOT NUMBER. IT HAS OCCURRED WITH ALL SIX OF THE COLORS THAT WE ORDER. THE INSTRUCTIONAL DVD PROVIDED BY NEOTECH IS USED TO TRAIN ALL ASSOCIATES ON THE USE OF THIS PRODUCT. THEREFORE, WE DON'T BELIEVE USER ERROR IS THE CAUSE. CURRENTLY, WE ARE INVESTIGATING OTHER PRODUCTS. PLEASE NOTE: WE HAVE REPORTED 5 OTHER INCIDENTS TO MEDSUN IN 2011.======================MANUFACTURER RESPONSE FOR NEOBAR ETT(PER SITE REPORTER).======================THE MANUFACTURER REQUESTS THAT THE PRODUCT BE RETURNED TO THEM, WHICH WE WILL BE DOING AND WILL BE SENDING OUT A REPRESENTATIVE TO MAKE CERTAIN WE ARE USING THESE DEVICES CORRECTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEOBAR ENDOTRACHEAL TUBE HOLDER CBH NEOTECH PRODUCTS, INC N711 MICRO WHITE *

    Patients

    Seq Age Sex Outcome Treatment
    1 2 MO