BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 2220869 · Received August 12, 2011

    Report

    Report Number
    2220869
    Event Type
    Malfunction
    Date Received
    August 12, 2011
    Date of Event
    July 13, 2011
    Report Date
    July 14, 2011
    Manufacturer
    ANGIODYNAMICS
    Product Code
    LJT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AR, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A PATIENT WITH SICKLE CELL DISEASE HAD A SUBCLAVIAN INFUSE-A-PORT. ON RECENT INFUSION, THERE WAS PAIN AT THE LEVEL OF INFUSE-A-PORT CHAMBER. RADIOGRAPH DEMONSTRATES FRAGMENTED TUBING, WHICH HAS MIGRATED INTO THE RIGHT VENTRICLE AND PULMONARY OUTFLOW TRACT/PULMONARY ARTERY. PERCUTANEOUS FOREIGN BODY RETRIEVAL IS REQUESTED.======================MANUFACTURER RESPONSE FOR VASCULAR ACCESS PORT, VASCULAR(PER SITE REPORTER)======================WILL PROVIDE MFG WITH COPY OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * PORT, CATHETER, IMPLANTED LJT ANGIODYNAMICS * 955568

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR OTHER