BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CURITY 3.0MM CUFFED

    MDR report key: 2030548 · Received March 18, 2011

    Report

    Report Number
    2936999-2011-00214
    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
    JOH
    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-INTUBATION WITH ANOTHER TUBE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention