BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEONATAL & PEDIATRIC ENDOTRACHEAL TUBE HOLDER

    MDR report key: 1062965 · Received June 13, 2008

    Report

    Report Number
    1217052-2008-00086
    Event Type
    Injury
    Date Received
    June 13, 2008
    Date of Event
    April 30, 2008
    Report Date
    May 16, 2008
    Manufacturer
    SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.
    Product Code
    CBH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    NC, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    USER ALLEGES ENDOTRACHEAL TUBE SLIPPED THROUGH THE ENDOTRACHEAL TUBE HOLDER. HOSPITAL WAS USING WITH A MALLINCKRODT ENDOTRACHEAL TUBE. NO ADVERSE OUTCOME OTHER THAN REPLACING TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEONATAL & PEDIATRIC ENDOTRACHEAL TUBE HOLDER 73 BTR- ENDOTRACHEAL TUBE HOLDER CBH SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. * 7038

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DAY SHERIDAN/HUDSON ENDOTRACHEAL TUBE