BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTEX BLUE LINE ULTRA TRACHEOSTOMY TUBE

    MDR report key: 2123552 · Received June 9, 2011

    Report

    Report Number
    2183502-2011-00467
    Event Type
    Malfunction
    Date Received
    June 9, 2011
    Report Date
    June 7, 2011
    Manufacturer
    SMITHS MEDICAL INTERNATIONAL LTD.
    Product Code
    BTO
    PMA / PMN Number
    K030381
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    UNKNOWN

    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 TRACHEOSTOMY TUBE WAS DEFLATING AT THE CUFF AFTER SEVERAL HOURS IN SITU. REPLACEMENT WAS REQUIRED. NO INCIDENT RELATED MEDICAL SEQUELA WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROTEX BLUE LINE ULTRA TRACHEOSTOMY TUBE BTO -TUBE, TRACHEOSTOMY (W/WO CONNECTOR) BTO SMITHS MEDICAL INTERNATIONAL LTD. NA 1857742

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK