BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHILEY

    MDR report key: 3243023 · Received July 18, 2013

    Report

    Report Number
    2936999-2013-00521
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    June 20, 2013
    Report Date
    June 21, 2013
    Manufacturer
    COVIDIEN
    Product Code
    JOH
    PMA / PMN Number
    K962173
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PENDING RECEIPT OF SAMPLE FOR ANALYSIS. IF SAMPLE IS RECEIVED, A SUMMARY OF THE INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    COVIDIEN RECEIVED A REPORT, THE INNER CANNULA WAS CRACKED ALONG THE LINE OF THE CANNULA. REPORTER CONFIRMED THIS WAS DISCOVERED DURING ROUTINE CLEANING OF THE DEVICE. REPORTER CONFIRMED THAT THE OUTER CANNULA WAS NOT REPLACED, ONLY THE INNER CANNULA. CUSTOMER CONFIRMED THE PT IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335534 SHILEY CUFFLESS TRACH TUBE JOH COVIDIEN 120202096X

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR