BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX BLUE LINE UNCUFFED TRACHEOSTOMY TUBE

    MDR report key: 1933121 · Received December 13, 2010

    Report

    Report Number
    2183502-2010-00574
    Event Type
    Malfunction
    Date Received
    December 13, 2010
    Date of Event
    November 1, 2010
    Report Date
    December 7, 2010
    Manufacturer
    SMITHS MEDICAL INTERNATIONAL LTD
    Product Code
    BSR
    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 FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVAL.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT STATES THAT AN HME VALVE COULD NOT BE REMOVED FROM THE 15MM CONNECTOR OF THE IN SITU TRACHEOSTOMY TUBE. THE TRACH WAS REMOVED AND REPLACED. THE PT RECOVERED WITH NO INCIDENT RELATED MEDICAL SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PORTEX BLUE LINE UNCUFFED TRACHEOSTOMY TUBE TRACHEOSTOMY TUBE BSR SMITHS MEDICAL INTERNATIONAL LTD NA 1569470

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK