BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CURITY 3.0MM CUFFED

    MDR report key: 2030618 · Received March 18, 2011

    Report

    Report Number
    2936999-2011-00215
    Event Type
    Injury
    Date Received
    March 18, 2011
    Date of Event
    February 1, 2011
    Report Date
    February 24, 2011
    Manufacturer
    COVIDIEN, FORMERLY TYCO HE
    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 UNKNOWN THEREFORE THE DATE OF MANUFACTURE CAN NOT 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 MANUFACTURER. IF SIGNIFICANT INFORMATION 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 HILO ENDOTRACHEAL TUBE IS OF ESSENTIALLY IDENTICAL DESIGN AND IS DISTRIBUTED IN THE UNITED STATES. THE 510K NUMBER FOR THE HILO ENDOTRACHEAL TUBE IS K871204.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE CUFF ON THE PATIENTS TUBE COULD NOT BE INFLATED. THE PATIENT REQUIRED RE INTUBATION WITH ANOTHER TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CURITY 3.0MM CUFFED ENDOTRACHEAL TUBE BTR COVIDIEN, FORMERLY TYCO HE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention