BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEOBAR

    MDR report key: 3581298 · Received January 3, 2014

    Report

    Report Number
    2025917-2014-00001
    Event Type
    Injury
    Date Received
    January 3, 2014
    Report Date
    April 15, 2013
    Manufacturer
    NEOTECH PRODUCTS, INC.
    Product Code
    CBH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL INSPECTION OF THE RETURNED DEVICE REVEALED THAT ONE OF THE ADHESIVE TABS HAD SEPARATED FROM THE NEOBAR. PHOTOS ARE PROVIDED (PAGE 4 OF 4) WITH THIS REPORT. THE COMPLAINANT STATED THAT THE NEOBAR HAD BEEN IN PLACE FOR TEN DAYS AT THE TIME OF THE INCIDENT. IT APPEARS THAT THE "DIRECTIONS FOR USE" WERE NOT FOLLOWED, AS THEY STATE THAT THE DEVICE SHOULD BE CHANGED "EVERY 5-7 DAYS." THERE WAS NO FURTHER EVALUATION PERFORMED, AS THIS IS KNOWN ISSUE WITH THIS DEVICE. 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. A SUPPLEMENTAL REPORT WILL BE PROVIDED SHOULD ANY FURTHER PERTINENT INFORMATION BECOME AVAILABLE. THIS IS THE FINAL REPORT.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT, "THE NEOBAR BROKE FREE FROM THE ADHESIVE TAB THUS DISLODGING THE ETT TUBE, REQUIRING THE ANESTHESIOLOGIST TO REINTUBATE PT." THE DEVICE HAD BEEN IN PLACE FOR TEN DAYS AT THE TIME THE EXTUBATION OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3750 NEOBAR ET TUBE HOLDER CBH NEOTECH PRODUCTS, INC. N715H 22775

    Patients

    Seq Age Sex Outcome Treatment
    1 2 MO Required Intervention