BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHILEY

    MDR report key: 3921924 · Received May 28, 2014

    Report

    Report Number
    2936999-2014-00458
    Event Type
    Malfunction
    Date Received
    May 28, 2014
    Date of Event
    April 1, 2014
    Report Date
    April 29, 2014
    Manufacturer
    COVIDIEN
    Product Code
    JOH
    PMA / PMN Number
    K962173
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). COVIDIEN IS ATTEMPTING TO COLLECT SAMPLE FOR FAILURE ANALYSIS. IF THE SAMPLE IS RECEIVED, A SUMMARY OF THE INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED. A COVIDIEN INVESTIGATION FOUND NO EVIDENCE OF ISSUES DURING THE MANUFACTURING PROCESS OF THE COMPONENT. THE ROOT CAUSE IS NOT RELATED TO MANUFACTURING PROCESS. THERE ARE MANUFACTURING CONTROLS IN PLACE TO DETECT THIS DEFECT. (B)(4).

    Description of Event or Problem · 1

    COVIDIEN RECEIVED A REPORT THE INNER CANNULA OF THE TRACHEAL TUBE COMES OFF SOMETIMES. COVIDIEN IS ATTEMPTING TO GATHER FURTHER DETAILS ASSOCIATED TO THE CIRCUMSTANCES OF THIS REPORT. INVESTIGATION EFFORTS ARE ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314908 SHILEY LOW PRESSURE CUFFED TRACH TUBE JOH COVIDIEN

    Patients

    Seq Age Sex Outcome Treatment
    1