BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOBAR

    MDR report key: 2854638 · Received October 8, 2012

    Report

    Report Number
    2854638
    Event Type
    Malfunction
    Date Received
    October 8, 2012
    Date of Event
    September 14, 2012
    Report Date
    October 8, 2012
    Manufacturer
    NEOTECH
    Product Code
    BZA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE NEOBAR IS A DEVICE THAT HOLDS THE ENDOTRACHEAL TUBE IN PLACE FOR NEONATAL PATIENTS. THERE ARE ADHESIVE TABS PREASSEMBLED ONTO THE BAR. THE TABS ARE ADHERED TO THE SIDES OF THE PATIENT'S FACE TO SECURE THE BAR. THIS DEVICE IS RECOMMENDED FOR 5-7 DAYS OF USE BEFORE REPLACEMENT. IN THIS CASE THE NEOBAR WAS IN PLACE FOR 12 HOURS. ONE END OF THE NEOBAR MALFUNCTIONED IN THAT IT CAME APART FROM THE ADHESIVE TAB. AS A RESULT THERE WAS AN ACCIDENTAL EXTUBATION. THE PATIENT WAS REINTUBATED AGAIN WITHOUT HARM. THIS MALFUNCTION HAS HAPPENED WITH MORE THAN ONE NEOBAR AND WITH MORE THAN ONE SIZE. SPECIFICALLY WE HAVE EXPERIENCED THE N713 AND THE N712 MODELS TO COME APART WHILE IN USE. THE MANUFACTURER HAS REPLIED THAT THEY HAVE AN IMPROVED PRODUCT TO REPLACE OUR STOCK. THE ADHESIVE TABS NOW HAVE A "WELD" TO PREVENT THE TABS FROM SEPARATING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEOBAR CONNECTOR, AIRWAY (EXTENSION) BZA NEOTECH N713 *

    Patients

    Seq Age Sex Outcome Treatment
    1 24 *