BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX BLUE LINE ENDOBRONCHIAL DOUBLE LUMEN TUBES

    MDR report key: 2140356 · Received June 17, 2011

    Report

    Report Number
    2183502-2011-00488
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    May 18, 2011
    Report Date
    June 16, 2011
    Manufacturer
    SMITHS MEDICAL INTL., LTD.
    Product Code
    CBI
    PMA / PMN Number
    K953483
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER HAS NOT YET RETURNED THE DEVICE TO THE MFR FOR DEVICE EVAL. WHEN AND IF THE DEVICE BECOMES AVAILABLE AND IS RETURNED AND EVALUATED, THE MFR WILL FILE A F/U REPORT DETAILING THE RESULTS OF THE EVAL.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT ALLEGES THAT THE ENDOBRONCHIAL TUBE WAS DEFLATING AT THE PILOT BALLOON AFTER AN UNK AMOUNT OF TIME IN SITU. REPLACEMENT WAS REQUIRED. NO INCIDENT RELATED MEDICAL SEQUELAE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PORTEX BLUE LINE ENDOBRONCHIAL DOUBLE LUMEN TUBES CBI - TRACHEAL/BRONCHIAL DIFFERENTIAL VENTILATION TUBE CBI SMITHS MEDICAL INTL., LTD. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK