BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHILEY

    MDR report key: 3801896 · Received February 7, 2014

    Report

    Report Number
    2936999-2014-00100
    Event Type
    Malfunction
    Date Received
    February 7, 2014
    Date of Event
    January 1, 2014
    Report Date
    January 10, 2014
    Manufacturer
    COVIDIEN
    Product Code
    JOH
    PMA / PMN Number
    K962173
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE ASSOCIATED TO THIS REPORT IS EXPECTED TO BE RETURNED FOR ANALYSIS. IF THE SAMPLE IS RECEIVED, A SUMMARY OF THE INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    CUSTOMER REPORTS THAT DURING PRE-TESTING, THE INTERNAL CANNULA COULD NOT BE LOCKED IN THE TRACH TUBE. NO PT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    80709 SHILEY CUFFLESS FENESTRATED TRACH TUBE JOH COVIDIEN 13D0588JZX

    Patients

    Seq Age Sex Outcome Treatment
    1