BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHILEY

    MDR report key: 3142929 · Received May 29, 2013

    Report

    Report Number
    2936999-2013-00403
    Event Type
    Injury
    Date Received
    May 29, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 7, 2013
    Manufacturer
    COVIDIEN
    Product Code
    JOH
    PMA / PMN Number
    K962173
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO SAMPLE IS EXPECTED TO BE RETURNED. WITHOUT THE ACTUAL COMPLAINT SAMPLE A FULL INVESTIGATION CANNOT BE CARRIED OUT; THEREFORE, WE ARE UNABLE TO DETERMINE THE CAUSE FOR THIS SPECIFIC EVENT. INFORMATION OF THIS NATURE IS INCLUDED IN OUR DATABASE AND MONITORED THROUGH TRENDING.

    Description of Event or Problem · 1

    COVIDIEN RECEIVED A REPORT STATING THE INNER CANNULA OF THE REPORTED DEVICE WAS NOT LOCKING PROPERLY IN PLACE. THE REPORTER STATED THAT DECANNULATION AND RECANNULATION OF A REPLACEMENT TUBE WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233995 SHILEY CUFFLESS TRACH TUBE JOH COVIDIEN

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention