BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CURITY 7.0MM CUFFED

    MDR report key: 1940462 · Received December 20, 2010

    Report

    Report Number
    2936999-2010-01401
    Event Type
    Injury
    Date Received
    December 20, 2010
    Date of Event
    November 26, 2010
    Report Date
    December 3, 2010
    Manufacturer
    COVIDIEN, FORMERLY TYCO HEALTHCARE
    Product Code
    BTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE HISTORY RECORD FOR THE LOT NUMBER PROVIDED WILL BE REVIEWED. IF THE SAMPLE IS RETURNED A FAILURE INVESTIGATION WILL BE PERFORMED. IF SIGNIFICANT INFO IS OBTAINED FROM THE INVESTIGATION, A SUMMARY OF THE INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. THE DEVICE IN THE INCIDENT IS NOT DISTRIBUTED IN THE US, HOWEVER THE HILO ENDOTRACHEAL TUBE IS OF ESSENTIALLY IDENTICAL DESIGN AND IS DISTRIBUTED IN THE US. THE 510K NUMBER FOR THE HILO ENDOTRACHEAL TUBE IS K871204.

    Description of Event or Problem · 1

    THE COVIDIEN REP IN FRANCE RECEIVED A REPORT FROM THE CUSTOMER THAT STATED: "THE BALLOON BURST DURING THE OPERATION AND THE CATHETER BECAME LESS RIGID." "THE PT HAD TO BE RE INTUBATED, BUT NO CONSEQUENCE ON THE VENTILATION AS THE PT WAS BEING MONITORED DURING THE OPERATION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CURITY 7.0MM CUFFED ENDOTRACHEAL TUBE BTR COVIDIEN, FORMERLY TYCO HEALTHCARE 10192283042

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention