BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX UNIPERC ADJUSTABLE FLANGE TRACHEOSTOMY TUBES

    MDR report key: 1920599 · Received December 6, 2010

    Report

    Report Number
    2183502-2010-00565
    Event Type
    Malfunction
    Date Received
    December 6, 2010
    Date of Event
    October 16, 2010
    Report Date
    December 2, 2010
    Manufacturer
    SMITHS MEDICAL INTERNATIONAL, LTD
    Product Code
    BTO
    PMA / PMN Number
    K083031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 FOLLOW-UP 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 2 DAYS IN SITU. REPLACEMENT WAS REQUIRED. NO INCIDENT RELATED MEDICAL SEQUELAE WAS REPORTED.

    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 1797623

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization