BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIBER-OPTIC BRONCHOSCOPE DUAL-AXIS SWIVEL ADAPTER

    MDR report key: 1230604 · Received September 8, 2008

    Report

    Report Number
    9610530-2008-00034
    Event Type
    Malfunction
    Date Received
    September 8, 2008
    Date of Event
    August 7, 2008
    Report Date
    August 11, 2008
    Manufacturer
    SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.
    Product Code
    BZA
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    IN, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    USER ALLEGES THEY COULD NOT VENTILATE THE PT. THEY REMOVED THE SWIVEL AND LOOKED INSIDE, AND FOUND ANOTHER CAP WEDGED INSIDE. NO ADVERSE OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FIBER-OPTIC BRONCHOSCOPE DUAL-AXIS SWIVEL ADAPTER 73 BZA - CONNECTOR, BREATHING CIRCUIT, SINGLE -USE BZA SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. * 1103875

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR