BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX TRACHEOSTOMY TUBE D.I.C. CUFFED

    MDR report key: 1966822 · Received December 17, 2010

    Report

    Report Number
    2183502-2010-00590
    Event Type
    Malfunction
    Date Received
    December 17, 2010
    Date of Event
    November 15, 2010
    Report Date
    December 15, 2010
    Manufacturer
    SMITHS MEDICAL INTL LTD
    Product Code
    BTO
    PMA / PMN Number
    K934465
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    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

    PT REPORTED THAT THE PRODUCT WAS IN USE AND DEVELOPED A LEAK. THE PRODUCT WAS FOUND TO BE LEAKING AND THE LEAKAGE SOURCE WAS CONFIRMED TO BE THE INFLATION LINE. USER REPORTED THE DEVICE WAS REMOVED AND REPLACED. NO INCIDENT RELATED MEDICAL SEQUELA REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PORTEX TRACHEOSTOMY TUBE D.I.C. CUFFED BTO - TRACHEOSTOMY TUBE BTO SMITHS MEDICAL INTL LTD NA 1658674

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK