BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PORT-A-CATH II POLYSULFONE/TITANIUM SYSTEM

    MDR report key: 265243 · Received February 17, 2000

    Report

    Report Number
    265243
    Event Type
    Injury
    Date Received
    February 17, 2000
    Date of Event
    December 15, 1999
    Report Date
    February 14, 2000
    Manufacturer
    DELTEC SIMS DELTEC, INC.
    Product Code
    LJT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    POSSIBLE MALFUNCTION OF PORT-A-CATH. DR REPORTED CATHETER HAD COME LOOSE FROM PORT. PT CAME TO SAME DAY SURGERY DUE TO PORT-A-CATH MALFUNCTION. DURING PROCEDURE CATHETER WAS FOUND TO BE DETACHED FROM RESERVOIR. CATHETER COULD NOT BE IDENTIFIED. PT TAKEN TO X-RAY FOR RETRIEVAL OF CATHETER. CATHETER WAS LYING ACROSS HEART, AND DIFFICULT TO REMOVE. REMOVAL WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PORT-A-CATH II POLYSULFONE/TITANIUM SYSTEM * LJT DELTEC SIMS DELTEC, INC. L67456 67456

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| O DEVICE SENT TO BIOMEDICAL CONSULTING SVCS.