BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX BLUE LINE SACETT SUCTION ABOVE THE CUFF TRACHEAL TUBE

    MDR report key: 1893843 · Received November 1, 2010

    Report

    Report Number
    2183502-2010-00508
    Event Type
    Malfunction
    Date Received
    November 1, 2010
    Date of Event
    September 30, 2010
    Report Date
    October 30, 2010
    Manufacturer
    SMITHS MEDICAL INTERNATIONAL LTD.
    Product Code
    BTR
    PMA / PMN Number
    K081086
    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 REC'D THAT STATES THAT THE INFLATION LINE DETACHED FROM THE TRACHEOSTOMY TUBE AFTER 2 HRS IN SITU. THERE WAS NO REPORT OF INCIDENT RELATED MEDICAL SEQUELAE.

    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 1727191

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK