BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CURITY 7.5MM CUFFED

    MDR report key: 1892352 · Received October 27, 2010

    Report

    Report Number
    2936999-2010-01291
    Event Type
    Injury
    Date Received
    October 27, 2010
    Date of Event
    September 27, 2010
    Report Date
    September 29, 2010
    Manufacturer
    COVIDIEN/FORMERLY TYCO HEALTHCARE
    Product Code
    BTR
    PMA / PMN Number
    K871204
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TUBE WAS DISCARDED AND THEREFORE, UNAVAILABLE FOR FAILURE INVESTIGATION. THE DEVICE HISTORY RECORD FOR THE LOT NUMBER WAS REVIEWED AND THERE WERE NO NON-CONFORMANCES DURING THE MFG OF THIS LOT. THE DEVICE IN THE INCIDENT IS NOT DISTRIBUTED IN THE UNITED STATES, HOWEVER, THE HI/LO ENDOTRACHEAL TUBE IS OF ESSENTIALLY IDENTICAL DESIGN AND IS DISTRIBUTED IN THE UNITED STATES. THE 510K NUMBER FOR THE HI/LO ENDOTRACHEAL TUBE IS K871204.

    Description of Event or Problem · 1

    THE COVIDIEN REPRESENTATIVE IN FRANCE RECEIVED A REPORT THAT THE CUSTOMER HAD AN ENDOTRACHEAL TUBE WHERE THE BALLOON WAS DEFLATING AND THE PT REQUIRED A NON-ROUTINE REPLACEMENT OF THE TUBE. THE TUBE WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CURITY 7.5MM CUFFED ENDOTRACHEAL TUBE BTR COVIDIEN/FORMERLY TYCO HEALTHCARE 7.5MM 10132353042

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention