BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESPIRATORY SUPPORT PRODUCTS, INC.

    MDR report key: 527971 · Received April 14, 2004

    Report

    Report Number
    MW1032085
    Event Type
    Injury
    Date Received
    April 14, 2004
    Date of Event
    April 12, 2004
    Report Date
    April 13, 2004
    Manufacturer
    SIMS SMITHS INDUSTRIES MEDICAL SYSTEMS
    Product Code
    BTR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    A LITTLE PIECE OF WHITE PLASTIC WAS LODGED IN THE LUMEN AT THE ADAPTER WHERE IT STITCHES TO THE ENDOTRACHEAL TUBE. IT COULD HAVE GONE INTO THE PT'S LUNGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESPIRATORY SUPPORT PRODUCTS, INC. STANDARD CONNECTOR WITH SIDEPORT BTR SIMS SMITHS INDUSTRIES MEDICAL SYSTEMS 10038-082 1255

    Patients

    Seq Age Sex Outcome Treatment
    1 7 DAY Life Threatening