BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMART PORT

    MDR report key: 4960221 · Received July 28, 2015

    Report

    Report Number
    MW5044986
    Event Type
    Injury
    Date Received
    July 28, 2015
    Date of Event
    April 27, 2015
    Report Date
    July 28, 2015
    Manufacturer
    ANGIODYNAMICS
    Product Code
    LJT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PATIENT WITH INTRAPERITONEAL PORT-A-CATH IN THE RIGHT UPPER QUADRANT. DYE STUDY SHOWED TUBING WAS DETACHED FROM THE IP PORT. PATIENT TAKEN TO THE OPERATING ROOM FOR EXPLANTATION. THE PORT AND CONNECTED PIECE OF THE CATHETER WERE REMOVED INTACT AND THEN THE DISTAL PIECE OF THE CATHETER HAD TO BE RETRIEVED FROM THE INTRAPERITONEAL SPACE. THE ENTIRE PORT-A-CATH WAS REMOVED WITH THIS PROCEDURE. PATIENT HAD PORT IN PLACE APPROXIMATELY 8 MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    488134 SMART PORT PORT-A-CATH LJT ANGIODYNAMICS PORT CTLPTI 6.6 FR 4731945

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention CARBOPLATIN| TAXOL