BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHILEY

    MDR report key: 3142903 · Received May 29, 2013

    Report

    Report Number
    2936999-2013-00396
    Event Type
    Injury
    Date Received
    May 29, 2013
    Date of Event
    April 27, 2013
    Report Date
    April 30, 2013
    Manufacturer
    COVIDIEN
    Product Code
    JOH
    PMA / PMN Number
    K962173
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO SAMPLE WAS DISCARDED THEREFORE NOT AVAILABLE FOR ANALYSIS. WITHOUT THE ACTUAL COMPLAINT SAMPLE A FULL INVESTIGATION CANNOT BE CARRIED OUT; THEREFORE, WE ARE UNABLE TO DETERMINE THE CAUSE FOR THIS SPECIFIC EVENT. MANUFACTURING CONTROLS ARE IN PLACE TO DETECT RELATED ISSUES AND TO REDUCE THE POTENTIAL FOR OCCURRENCE DURING THE MANUFACTURING PROCESS. INFORMATION OF THIS NATURE IS INCLUDED IN OUR DATABASE AND MONITORED THROUGH TRENDING.

    Description of Event or Problem · 1

    THE REPORTER STATED THAT THE SNAPHEAD SEPARATED FORM THE TUBE DURING PT USE. THE REPORTED STATED THE DECANNULATION AND RECANNULATION OF A REPLACEMENT TUBE WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233836 SHILEY DISPOSABLE CANNULA LOW PRESSURE CUF JOH COVIDIEN 13A0144J2X

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention