BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2PC VSYS W/9FR INTRO KIT/2.8OD

    MDR report key: 1820717 · Received August 27, 2010

    Report

    Report Number
    1219930-2010-00678
    Event Type
    Injury
    Date Received
    August 27, 2010
    Report Date
    August 2, 2010
    Manufacturer
    UNITED STATES SURGICAL
    Product Code
    LJT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: THE PT WAS OPERATED ON (B)(6) 2010, AFTER 3 MONTHS OF THIS, THE CATHETER BROKE AT THE JOINT. THIS OCCURRED DURING THE PT'S SIXTH CHEMOTHERAPY CYCLE, THE DRUG WENT OUT OF THE CATHETER TOWARDS THE SKIN CAUSING FIRST DEGREE BURNS. THERE WAS RE-OPERATION TO REMOVE THE PIECE BUT NO ADD'L BLOOD LOSS/TISSUE DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 2PC VSYS W/9FR INTRO KIT/2.8OD CHEMOSITE PORT LJT UNITED STATES SURGICAL 000000

    Patients

    Seq Age Sex Outcome Treatment
    1 Other