BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHILEY

    MDR report key: 3072321 · Received April 17, 2013

    Report

    Report Number
    2936999-2013-00293
    Event Type
    Injury
    Date Received
    April 17, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 18, 2013
    Manufacturer
    COVIDIEN
    Product Code
    JOH
    PMA / PMN Number
    K962173
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE
    Health Professional
    N

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE CLIENT REPORTED THAT WHEN THEY TRY TO PUT THE PHONATION VALVE, THE INNER CANNULA BREAKS AT THE JUNCTION (INNER CANNULA CONNECTION). THE CALLER REPORTED THAT HAD TO REMOVE THE BROKEN PIECES AND IT WAS QUITE DIFFICULT. THE INFORMATION DOES NOT CONFIRM THAT DECANNULATION/RECANNULATION OF A REPLACEMENT TUBE WAS REQUIRED. COVIDIEN IS ATTEMPTING TO GATHER FURTHER DETAILS SURROUNDING THE CIRCUMSTANCES OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165631 SHILEY CUFFLESS TRACH TUBE JOH COVIDIEN 120600273X

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| O