BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHILEY

    MDR report key: 2864444 · Received December 5, 2012

    Report

    Report Number
    2936999-2012-00639
    Event Type
    Malfunction
    Date Received
    December 5, 2012
    Date of Event
    November 5, 2012
    Report Date
    November 6, 2012
    Manufacturer
    COVIDIEN, FORMERLY TYCO HEALTHCARE
    Product Code
    JOH
    PMA / PMN Number
    K945513
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE IS CURRENTLY IN TRANSIT TO THE MANUFACTURING SITE FOR ANALYSIS.

    Description of Event or Problem · 1

    CUSTOMER STATES SUCTION CATHETER CANNOT BE PUSHED THROUGH CANNULA PROPERLY. THE RESISTANCE REQUIRES FORCE. THEREBY CATHETER CAN BE PUSHED UNCONTROLLED OUT OF THE CANNULA END. NO PATIENT HARMED OR ABNORMALITY. BUT YOU CAN RECOGNIZE THIS DEFECT OUT OF THE PATIENT, WHEN YOU PUSH THE CATHETER. ALSO YOU CAN RECOGNIZE A FLANGE/BULGE AT THE INNER CANNULA WALL AT THE CANNULA TIP. THE CUSTOMER CONFIRMED NO PATIENT HARM OR ABNORMALITY. EFFORTS TO COLLECT FURTHER DETAILS SURROUNDING THE CIRCUMSTANCES OF THIS REPORT HAVE BEEN MADE. THE CUSTOMER DID CONFIRM THE RECANNULATION OF A REPLACEMENT TUBE WAS NOT REQUIRED AS A RESULT OF THE REPORTED ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHILEY NEONATAL TRACH TUBE JOH COVIDIEN, FORMERLY TYCO HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1