BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMART PORT CT

    MDR report key: 1790467 · Received August 4, 2010

    Report

    Report Number
    MW5017008
    Event Type
    Malfunction
    Date Received
    August 4, 2010
    Date of Event
    July 19, 2010
    Report Date
    August 4, 2010
    Manufacturer
    ANGIODYNAMICS INCORPORATED
    Product Code
    LJT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OR, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SMARTPORT MALFUNCTION/DEFECT. FLUOROSCOPY SHOWED PORT WAS LEAKING. WHEN REMOVED A LARGE TEAR WAS FOUND ABOUT 3.5 INCHES FROM THE HUB. OPERATIVE REPORT STATES "EVALUATION OF CATHETER REVEALED ALMOST COMPLETE CIRCUMFERENTIAL DISRUPTION OF THE CATHETER IN AN OBLIQUE FASHION WHICH APPEARED TO BE MOST CONSISTENT WITH A PRESSURE RELATED DYSFUNCTION." DATES OF USE: (B)(6) 2010 ¿ (B)(6) 2010. DIAGNOSIS OR REASON FOR USE: VENOUS ACCESS FOR CHEMOTHERAPY. EVENT ABATED AFTER USE: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMART PORT CT SMART PORT LJT ANGIODYNAMICS INCORPORATED 503283

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR