BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHILEY

    MDR report key: 2833418 · Received October 26, 2012

    Report

    Report Number
    2936999-2012-00554
    Event Type
    Malfunction
    Date Received
    October 26, 2012
    Date of Event
    October 1, 2012
    Report Date
    October 5, 2012
    Manufacturer
    COVIDIEN, FORMERLY TYCO HEALTHCARE
    Product Code
    JOH
    PMA / PMN Number
    K962173
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    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

    THE CALLER STATED THAT THEY OPENED THE PACKAGE AND FOUND THAT ONE END OF THE INNER CANNULA TUBE WAS SEALED. THE CALLER CONFIRMED THAT THE PACKAGING ITSELF LOOKED TO BE SEALED. CALLER CONFIRMED NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHILEY FENESTRATED LOW PRESSURE CUFFED TRA JOH COVIDIEN, FORMERLY TYCO HEALTHCARE 110900388

    Patients

    Seq Age Sex Outcome Treatment
    1