BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX SOFT SEAL CUFF ENDOTRACHEAL TUBE

    MDR report key: 3983879 · Received June 23, 2014

    Report

    Report Number
    2183502-2014-00431
    Event Type
    Malfunction
    Date Received
    June 23, 2014
    Date of Event
    May 20, 2014
    Report Date
    June 20, 2014
    Manufacturer
    SMITHS MEDICAL INTERNATIONAL LTD
    Product Code
    BTR
    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.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT ALLEGES THAT THE ENDOTRACHEAL TUBE WAS DEFLATING AT THE PILOT BALLOON AFTER 7 HOURS INTO SITU. NO INCIDENT RELATED MEDICAL SEQUELA WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    366117 PORTEX SOFT SEAL CUFF ENDOTRACHEAL TUBE BTR - ENDOTRACEAL TUBES BTR SMITHS MEDICAL INTERNATIONAL LTD NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK