BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOBAR

    MDR report key: 2436986 · Received February 1, 2012

    Report

    Report Number
    2436986
    Event Type
    Malfunction
    Date Received
    February 1, 2012
    Date of Event
    January 31, 2012
    Report Date
    February 1, 2012
    Manufacturer
    NEOTECH PRODUCTS, INC.
    Product Code
    CBH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    THIS IS ANOTHER INCIDENT INVOLVING NEOBAR ETT HOLDER IN WHICH THE TAB OF THE STABILIZATION PLATFORM SEPARATED FROM THE ADHESIVE CAUSING EXTUBATION OF THE ORAL ETT. RN AT BEDSIDE OBSERVED O2 SAT 74% AND NEOBAR TO BE DETACHED FROM ADHESIVE FACIAL DEVICE ON INFANT (SELF-EXTUBATED). MULTIPLE ATTEMPTS MADE TO REINTUBATE, UNABLE TO INTUBATE. PPV GIVEN AT 100% DURING ATTEMPTS TO INTUBATE, ANESTHESIA CALLED TO BEDSIDE AND SUCCESSFULLY INTUBATED THE INFANT. WE ARE UNABLE TO IDENTIFY A SPECIFIC COLOR OR LOT NUMBER. THIS IS A SERIOUS PROBLEM DUE TO THE POTENTIAL FOR HARM. WE HAVE REMOVED NEOBAR FROM THE SIX INTUBATED INFANTS CURRENTLY IN NICU AND REPLACED WITH TAPE. THE MANUFACTURER IS AWARE, PREVIOUS DEVICES HAVE BEEN RETURNED TO THEM FOR TESTING, AND THEY ARE SENDING A REPRESENTATIVE TO THE HOSPITAL.MANUFACTURER RESPONSE FOR ENDOTRACHEAL TUBE HOLDER(PER SITE REPORTER).THE MANUFACTURER REQUESTS THE PRODUCT BE RETURNED TO THEM FOR EVALUATION, WHICH WE WILL DO AND THEY ARE SENDING OUT A REPRESENTATIVE.

    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