BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX SOFT SEAL CUFF ENDOTRACHEAL TUBE

    MDR report key: 4232454 · Received October 24, 2014

    Report

    Report Number
    2183502-2014-00801
    Event Type
    Malfunction
    Date Received
    October 24, 2014
    Date of Event
    October 3, 2014
    Report Date
    October 24, 2014
    Manufacturer
    SMITHS MEDICAL MD, INC.
    Product Code
    BTR
    PMA / PMN Number
    K931735
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SMITHS MEDICAL HAS RECEIVED THE SAMPLE DEVICE. A FULL EVALUATION IS ANTICIPATED, BUT NOT YET BEGUN AS THE DEVICE IS CURRENTLY IN TRANSIT TO THE INVESTIGATION SITE. SMITHS MEDICAL WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVALUATION ONCE IT IS COMPLETED.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THE LISTED DEVICE WAS IN PATIENT USE, WITH A VENTILATOR, FOR APPROXIMATELY ONE WEEK WHEN THE INFLATION LINE WAS FOUND DETACHED FROM THE TRACHEAL TUBE. THE DEVICE WAS REPLACED. NO INCIDENT RELATED MEDICAL SEQUELA WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678001 PORTEX SOFT SEAL CUFF ENDOTRACHEAL TUBE BTR ENDOTRACHEAL TUBES BTR SMITHS MEDICAL MD, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR