BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHILEY

    MDR report key: 3893984 · Received June 9, 2014

    Report

    Report Number
    2936999-2014-00502
    Event Type
    Injury
    Date Received
    June 9, 2014
    Date of Event
    May 1, 2014
    Report Date
    May 14, 2014
    Manufacturer
    COVIDIEN
    Product Code
    JOH
    PMA / PMN Number
    K962173
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO SAMPLE IS EXPECTED TO BE RETURNED. WITHOUT THE ACTUAL COMPLAINT SAMPLE A FULL INVESTIGATION CANNOT BE COMPLETED; THEREFORE, WE ARE UNABLE TO DETERMINE THE CAUSE FOR THIS SPECIFIC EVENT. WE ARE UNABLE TO DETERMINE THE EXACT CAUSE FOR THIS SPECIFIC EVENT HOWEVER, MANUFACTURING CONTROLS ARE IN PLACE TO DETECT RELATED ISSUES AND TO REDUCE THE POTENTIAL FOR OCCURRENCE DURING THE MANUFACTURING PROCESS. INFORMATION OF THIS NATURE IS INCLUDED IN OUR DATABASE AND MONITORED THROUGH TRENDING.

    Description of Event or Problem · 1

    CUSTOMER REPORTS INNER CANNULA STICKS OUT THE END OF THE TRACH TUBE. COVIDIEN HAS ATTEMPTED TO GATHER FURTHER DETAILS SURROUNDING THE CIRCUMSTANCES OF THIS REPORT, WITHOUT SUCCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336571 SHILEY DISPOSABLE CANNULA CUFFLESS TRACH JOH COVIDIEN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention