BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEONATAL & PEDIATRIC ENDOTRACHEAL TUBE HOLDER

    MDR report key: 671078 · Received February 2, 2006

    Report

    Report Number
    1217052-2006-00010
    Event Type
    Injury
    Date Received
    February 2, 2006
    Date of Event
    November 27, 2005
    Report Date
    January 4, 2006
    Manufacturer
    SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.
    Product Code
    CBH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    USER ALLEGED THEY HAD ONE EVENT INVOLVING AN ENDOTRACHEAL TUBE HOLDER AND THE FOAM COMING AWAY FROM THE HOLDER. THE ENDOTRACHEAL TUBE CAME OUT. THE NURSE AND THERAPIST BAGGED PT AND PLACED ON N-CPAP. THE PT WAS REINTUBATED AND THERE WAS NO PT COMPROMISE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEONATAL & PEDIATRIC ENDOTRACHEAL TUBE HOLDER SUPPORT BREATHING TUBE CBH SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. NA 3721

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Required Intervention