BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHILEY

    MDR report key: 3142946 · Received May 29, 2013

    Report

    Report Number
    2936999-2013-00408
    Event Type
    Injury
    Date Received
    May 29, 2013
    Date of Event
    April 2, 2013
    Report Date
    May 8, 2013
    Manufacturer
    COVIDIEN
    Product Code
    JOH
    PMA / PMN Number
    K962173
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS EXPECTED TO BE RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    COVIDIEN RECEIVED A CUSTOMER REPORT STATING THAT THE DEVICE DEVELOPED A CUFF LEAK DURING PT USE. THE REPORTER STATES THAT DECANNULATION AND RECANNULATION OF A REPLACEMENT TUBE WAS REQUIRED. THE CUSTOMER REPORTED THAT THE REPLACEMENT TUBE LEAKED IN THE SAME MANNER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234026 SHILEY DISPOSABLE CANNULA FENESTRATED LOW JOH COVIDIEN 1210221JZX

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention