BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX BLUE LINE SACETT SUCTION ABOVE THE CUFF TRACHEAL TUBE

    MDR report key: 2070391 · Received April 18, 2011

    Report

    Report Number
    2183502-2011-00165
    Event Type
    Malfunction
    Date Received
    April 18, 2011
    Date of Event
    March 18, 2011
    Report Date
    April 15, 2011
    Manufacturer
    SMITHS MEDICAL INTERNATIONAL LTD
    Product Code
    BTR
    PMA / PMN Number
    K081086
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    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 FOR 10-12 DAYS WHEN THE TUBE DEVELOPED A KINK THAT... THE ENDOTRACHEAL TUBE WAS REMOVED AND REPLACED.

    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