BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEEKER

    MDR report key: 2842740 · Received November 16, 2012

    Report

    Report Number
    2842740
    Event Type
    Malfunction
    Date Received
    November 16, 2012
    Date of Event
    November 13, 2012
    Report Date
    November 16, 2012
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DQY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    CATHETER WAS HANDED FROM THE SCRUB TECH TO THE MD FROM STERILE PACKAGE. WHEN THE MD WAS ASSESSING THE DEVICE PRIOR TO PLACING IN PATIENT HE REALIZED THAT IT WAS BROKEN, AND HE REMOVED IT FROM CIRCULATION. THE CATHETER NEVER REACHED THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEEKER CROSSING SUPPORT CATHETER DQY BARD PERIPHERAL VASCULAR, INC. SEEKER CROSSING SUPPORT CATHETER VTWB3113

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR