BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHILEY

    MDR report key: 2833351 · Received October 26, 2012

    Report

    Report Number
    2936999-2012-00551
    Event Type
    Malfunction
    Date Received
    October 26, 2012
    Date of Event
    September 28, 2012
    Report Date
    October 1, 2012
    Manufacturer
    COVIDIEN, FORMERLY TYCO HEALTHCARE
    Product Code
    JOH
    PMA / PMN Number
    K955680
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION NOT YET AVAILABLE. PENDING RECEIPT OF SAMPLE FOR INVESTIGATION.

    Description of Event or Problem · 1

    CUSTOMER REPORTS THAT THE CANULA IS WARPED AND THAT THE PROPORTION OF CANULA SHIELD TO THE TUBE IS NOT PROPER. CUSTOMER REPORTED THAT THE DEVICE WAS NOT USED ON A PATIENT. COVIDIEN IS ATTEMPTING TO COLLECT FURTHER DETAILS RELATED TO THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHILEY CUFFED PEDIATRIC TRACH TUBE JOH COVIDIEN, FORMERLY TYCO HEALTHCARE 110401870X

    Patients

    Seq Age Sex Outcome Treatment
    1