BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX 8.5 SOFT SEAL CUFF TRACHEAL TUBE

    MDR report key: 2843797 · Received October 25, 2012

    Report

    Report Number
    2183502-2012-00497
    Event Type
    Malfunction
    Date Received
    October 25, 2012
    Date of Event
    September 26, 2012
    Report Date
    October 24, 2012
    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

    CUSTOMER HAS NOT YET RETURNED THE DEVICE TO THE MANUFACTURER FOR DEVICE EVAL. 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 EVAL.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT ALLEGES THAT THE ENDOTRACHEAL TUBE WAS LEAKING AFTER 20 HOURS IN SITU. NO INCIDENT RELATED MEDICAL SEQUELA WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PORTEX 8.5 SOFT SEAL CUFF TRACHEAL TUBE BTR - TUBE, TRACHEAL (W/WO CONNECTOR) BTR SMITHS MEDICAL INTERNATIONAL, LTD NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK