BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX UNIPERC ADJUSTABLE FLANGE TRACHEOSTOMY TUBES

    MDR report key: 2160487 · Received July 1, 2011

    Report

    Report Number
    2183502-2011-00518
    Event Type
    Malfunction
    Date Received
    July 1, 2011
    Date of Event
    May 23, 2011
    Report Date
    July 1, 2011
    Manufacturer
    SMITHS MEDICAL INTERNATIONAL LTD.,
    Product Code
    BTO
    PMA / PMN Number
    K083031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER HAS NOT YET RETURNED THE DEVICE TO THE MANUFACTURER 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 AFTER APPROX 2 WEEKS IN SITU, THE 15MM CONNECTOR DETACHES FROM THE SHAFT OF THE TRACHEOSTOMY TUBE WHICH REQUIRED REPLACEMENT. THE TRACH WAS REPLACED AND THE PT RECOVERED WITH NO INCIDENT RELATED MEDICAL SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PORTEX UNIPERC ADJUSTABLE FLANGE TRACHEOSTOMY TUBES BTO - TRACHEOSTOMY TUBE BTO SMITHS MEDICAL INTERNATIONAL LTD., NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization