BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHILEY

    MDR report key: 3252120 · Received July 24, 2013

    Report

    Report Number
    2936999-2013-00542
    Event Type
    Injury
    Date Received
    July 24, 2013
    Date of Event
    June 1, 2013
    Report Date
    June 25, 2013
    Manufacturer
    COVIDIEN
    Product Code
    JOH
    PMA / PMN Number
    K962173
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    COVIDIEN CTS REFERENCE # (B)(4). THE SAMPLE ASSOCIATED TO THIS REPORT IS CURRENTLY IN TRANSIT TO THE MANUFACTURING SITE FOR ANALYSIS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED: TUBE DEVELOPED A CRACK IN THE HUB. CUSTOMER REPORTED THAT DECANNULATION AND RECANNULATION OF A REPLACEMENT TUBE WAS REQUIRED. CUSTOMER CONFIRMED NO ADDITIONAL HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    345114 SHILEY DISPOSABLE CANNULA CUFFLESS TRACH JOH COVIDIEN 110900646X

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention