BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX BLUE LINE CUFFED ADJUSTABLE FLANGE TRACHEOSTOMY TUBES

    MDR report key: 2161716 · Received March 29, 2011

    Report

    Report Number
    2183502-2011-00124
    Event Type
    Malfunction
    Date Received
    March 29, 2011
    Date of Event
    February 28, 2011
    Report Date
    March 28, 2011
    Manufacturer
    SMITHS MEDICAL INTERNATIONAL, LTD.
    Product Code
    JOH
    PMA / PMN Number
    K962175
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER HAS NOT YET RETURNED THE DEVICE TO THE MANUFACTURER FOR DEVICE EVALUATION. WHEN AND IF THE DEVICE BECOMES AVAILABLE AND IS RETURNED AND EVALUATED THE MANUFACTURER WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVALUATION.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT ALLEGES THAT THE 15MM CONNECTOR DETACHES FROM THE SHAFT OF THE TRACHEOSTOMY TUBE WHICH REQUIRED REPLACEMENT. THE TRACH WAS REPLACED AND THE PATIENT RECOVERED WITH NO INCIDENT RELATED MEDICAL SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PORTEX BLUE LINE CUFFED ADJUSTABLE FLANGE TRACHEOSTOMY TUBES JOH - TUBE TRACHEOSTOMY AND TUBE CUFF JOH SMITHS MEDICAL INTERNATIONAL, LTD. NA 1839804

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK