BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CURITY 3.0MM CUFFED

    MDR report key: 2030615 · Received March 18, 2011

    Report

    Report Number
    2936999-2011-00213
    Event Type
    Injury
    Date Received
    March 18, 2011
    Date of Event
    February 1, 2011
    Report Date
    February 24, 2011
    Manufacturer
    COVIDIEN / FORMERLY TYCO HEALTHCARE
    Product Code
    BTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER IS UNK; THEREFORE, THE DATE OF MANUFACTURE CANNOT BE DETERMINED. IF THE SAMPLE IS RETURNED, A FAILURE INVESTIGATION WILL BE PERFORMED. THE SAMPLE RELATED TO THIS REPORT IS CURRENTLY IN TRANSIT TO THE MFR. IF SIGNIFICANT INFO IS IDENTIFIED 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 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 CUSTOMER REPORTED THAT THE CUFF ON THE PT'S TUBE COULD NOT BE INFLATED. THE PT REQUIRED RE INTUBATED WITH ANOTHER TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CURITY 3.0MM CUFFED ENDOTHRACHEAL TUBE BTR COVIDIEN / FORMERLY TYCO HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention