BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHILEY

    MDR report key: 3060298 · Received April 11, 2013

    Report

    Report Number
    2936999-2013-00279
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 15, 2013
    Manufacturer
    COVIDIEN / FORMERLY TYCOHEA
    Product Code
    JOH
    PMA / PMN Number
    K962173
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INCONCLUSIVE - INVESTIGATION IN PROGRESS. PENDING SAMPLE ANALYSIS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE INNER CANNULA OF PATIENTS TRACHEOSTOMY BECAME COMPLETELY DISLODGED FROM THE OUTER CANNULA WHILE STILL ATTACHED TO THE VENTILATOR. ON INSPECTION INNER TUBE FOUND NOT TO LOCK IN POSITION. THE CUSTOMER CONFIRMED THAT DECANNULATION AND RECANNULATION OF A REPLACEMENT TUBE WAS PERFORMED. COVIDIEN IS ATTEMPTING TO COLLECT FURTHER DETAILS SURROUNDING THE CIRCUMSTANCES OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156521 SHILEY CUFFLESS TRACH TUBE JOH COVIDIEN / FORMERLY TYCOHEA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention