BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX BLUE LINE SACETT SUCTION ABOVE THE CUFF TRACHEAL TUBE

    MDR report key: 2010295 · Received February 11, 2011

    Report

    Report Number
    2183502-2011-00021
    Event Type
    Malfunction
    Date Received
    February 11, 2011
    Report Date
    February 9, 2011
    Manufacturer
    SMITHS MEDICAL INTERNATIONAL LTD.
    Product Code
    BTR
    PMA / PMN Number
    K081086
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER HAS NOT YET RETURNED THE DEVICE TO THE MANUFACTURER FOR DEVICE EVALUATION. WHEN AND IF THE DEVICE BECOMES AVAILABLE AND IS RETURNED AND EVALUATED THE MANUFACTURER WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVALUATION.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT ALLEGES THAT THE ENDOTRACHEAL TUBE WAS IN SITU AND DURING VENTILATION WITH AN AMBU BAG THE 15 MM CONNECTOR BECAME DETACHED REQUIRING REPLACEMENT. NO INCIDENT RELATED MEDICAL SEQUELA WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PORTEX BLUE LINE SACETT SUCTION ABOVE THE CUFF TRACHEAL TUBE BTR - TRACHEAL TUBES BTR SMITHS MEDICAL INTERNATIONAL LTD. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK