BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX SOFT SEAL TRACHEAL TUBE

    MDR report key: 3933717 · Received April 3, 2014

    Report

    Report Number
    2183502-2014-00178
    Event Type
    Malfunction
    Date Received
    April 3, 2014
    Date of Event
    March 3, 2014
    Report Date
    April 2, 2014
    Manufacturer
    SMITHS MEDICAL INTERNATIONAL LTD.
    Product Code
    BTR
    PMA / PMN Number
    PREAMENDMENT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. METHOD: OTHER - A SAMPLE DEVICE WAS RETURNED AND IS CURRENTLY IN TRANSIT TO THE INVESTIGATION SITE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED STATING THAT DURING USE OF THE LISTED TRACHEAL TUBE, THE CUFF WAS FOUND TO BE DEFLATING FROM THE PILOT BALLOON. REPLACEMENT WAS REQUIRED. NO INCIDENT RELATED MEDICAL SEQUELA WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203283 PORTEX SOFT SEAL TRACHEAL TUBE BTR - TRACHEAL TUBES BTR SMITHS MEDICAL INTERNATIONAL LTD. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK