BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX BLUE LINE SACETT SUCTION ABOVE THE CUFF TRACHEAL TUBE

    MDR report key: 3252708 · Received July 15, 2013

    Report

    Report Number
    2183502-2013-00382
    Event Type
    Malfunction
    Date Received
    July 15, 2013
    Date of Event
    June 5, 2013
    Report Date
    July 12, 2013
    Manufacturer
    SMITHS MEDICAL INTL. LTD.
    Product Code
    BTR
    PMA / PMN Number
    K081086
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    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 ENDOTRACHEAL TUBE WAS IN SITU FOR UNREPORTED AMOUNT OF TIME WHEN THE TUBE DEVELOPED A KINK THAT INHIBITED THE FLOW OF OXYGEN. THE ENDOTRACHEAL TUBE WAS REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327853 PORTEX BLUE LINE SACETT SUCTION ABOVE THE CUFF TRACHEAL TUBE BTR- TRACHEAL TUBES BTR SMITHS MEDICAL INTL. LTD. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK