BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX NORTH FACING POLAR PREFORMED ENDOTRACHEAL TUBE

    MDR report key: 2844838 · Received November 2, 2012

    Report

    Report Number
    2183502-2012-00517
    Event Type
    Malfunction
    Date Received
    November 2, 2012
    Date of Event
    September 17, 2012
    Report Date
    November 1, 2012
    Manufacturer
    SMITHS MEDICAL INTERNATIONAL LTD.
    Product Code
    BTR
    PMA / PMN Number
    K931735
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    UNKNOWN

    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 TRACHEOSTOMY TUBE WAS DEFLATING AT THE CUFF AFTER AN UNKNOWN AMOUNT OF TIME IN SITU. REPLACEMENT WAS REQUIRED. NO INCIDENT RELATED MEDICAL SEQUELAE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PORTEX NORTH FACING POLAR PREFORMED ENDOTRACHEAL TUBE ENDOTRACHEAL TUBE, SINGLE-USE BTR SMITHS MEDICAL INTERNATIONAL LTD. NA 2186615

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK