BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHILEY

    MDR report key: 2932234 · Received January 22, 2013

    Report

    Report Number
    2936999-2013-00048
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Date of Event
    December 20, 2012
    Report Date
    December 25, 2012
    Manufacturer
    COVIDIEN, FORMERLY TYCOHEALTHCARE
    Product Code
    JOH
    PMA / PMN Number
    K945513
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION EFFORTS ARE CURRENTLY IN PROGRESS.

    Description of Event or Problem · 1

    DURING USE ON A PT, A NURSE AT HOSPITAL FOUND THE TUBE COULD NOT JOIN WITH THE CONNECTOR DEEPLY. NO PT HARM. THE INFORMATION PROVIDED DOES NOT CONFIRM IF THE TUBE WAS REPLACED. COVIDIEN HAS MADE ATTEMPTS TO GATHER ADDITIONAL INFORMATION RELATED TO THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31573 SHILEY PEDIATRIC TRACH TUBE JOH COVIDIEN, FORMERLY TYCOHEALTHCARE 120301807X

    Patients

    Seq Age Sex Outcome Treatment
    1