BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEOTECH NEOBAR

    MDR report key: 3760821 · Received April 9, 2014

    Report

    Report Number
    2025917-2014-00010
    Event Type
    Injury
    Date Received
    April 9, 2014
    Date of Event
    June 21, 2012
    Report Date
    August 16, 2012
    Manufacturer
    NEOTECH PRODUCTS, INC.
    Product Code
    CBH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED WAS NOT RETURNED TO THE MANUFACTURER AS IT WAS DISPOSED OF BY THE FACILITY. THE DIRECTIONS FOR USE WERE NOT BEING FOLLOWED BY THE STAFF AT THE TIME OF THE EVENT. NO INVESTIGATION WAS PERFORMED, AS THIS IS A KNOWN ISSUE WITH NEOBARS MANUFACTURED ON THIS DATE. DUE TO CONCERNS OF THE NEOBARS DISLODGING FROM THE ADHESIVE TABS, THE MANUFACTURING OF ALL NEOBARS HAS SINCE CHANGED TO INCLUDE A WELDING PROCEDURE AND NO REPORTS OF TAB SEPARATION HAVE BEEN REPORTED TO THIS DAY. THIS IS THE FINAL REPORT.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PLASTIC BAR OF THE ET TUBE HOLDER BECAME SEPARATED FROM THE ADHESIVE TAB AFTER 9 DAYS OF USE, WHICH IS BEYOND THE RECOMMENDED TIME FRAME OF USE (5-7 DAYS). THIS OCCURRED WHILE THE NURSE WAS REPOSITIONING THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212934 NEOTECH NEOBAR ET TUBE HOLDER CBH NEOTECH PRODUCTS, INC. N713 508-12

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention ET TUBE WAS BEING USED WITH THE NEOBAR