BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMART PORT LABEL P. N. 103035 REV. A

    MDR report key: 4935899 · Received July 17, 2015

    Report

    Report Number
    MW5044646
    Event Type
    Injury
    Date Received
    July 17, 2015
    Date of Event
    July 6, 2015
    Report Date
    July 17, 2015
    Manufacturer
    ANGIODYNAMICS
    Product Code
    LJS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2015 CT OF THORAX WITH CONTRAST WAS PERFORMED FOR F/U ON COLON CARCINOMA. RESULTS SHOWED AN INCIDENTAL PINCH OFF OF THE LEFT SIDED PORT-A-CATH THAT HAD EMBOLIZED INTO THE PULMONARY ARTERY. ON (B)(6) 2015 REMOVAL OF PORT-A-CATH WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    465706 SMART PORT LABEL P. N. 103035 REV. A POART-A-CATH LJS ANGIODYNAMICS 4763278

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention