BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIODYNAMICS

    MDR report key: 2993954 · Received February 27, 2013

    Report

    Report Number
    MW5029219
    Event Type
    Injury
    Date Received
    February 27, 2013
    Date of Event
    February 13, 2013
    Report Date
    February 27, 2013
    Manufacturer
    ANGIODYNAMICS
    Product Code
    LJT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PORT-A-CATH PLACED (B)(6) 2011 WAS IDENTIFIED ON CT ON (B)(6) 2013 AS HAVING BROKEN INTO TWO FRAGMENTS WITH ONE FRAGMENT EXTENDING INTO THE RIGHT ATRIUM. DEVICE FRAGMENTS REMOVED BY AN INTERVENTIONAL CARDIOLOGIST AT OUTSIDE INSTITUTION ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83909 ANGIODYNAMICS VORTEX PORT-A-CATH LJT ANGIODYNAMICS SPDX-16-1 523285

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention