BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORT-A-CATH

    MDR report key: 3766122 · Received April 14, 2014

    Report

    Report Number
    3766122
    Event Type
    Malfunction
    Date Received
    April 14, 2014
    Date of Event
    February 3, 2014
    Report Date
    April 14, 2014
    Manufacturer
    BARD ACCESS SYSTEMS INC.
    Product Code
    LJT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD A PORT MALFUNCTION. PORT PLACED APPROXIMATELY 3 YEARS AGO. PORT WAS IN THE RIGHT UPPER AND LATERAL PART OF THE PATIENT'S CHEST. A SMALL HOLE WAS SEEN IN THE BACK OF THE PLASTIC PORT. PORT REMOVED AND A NEW PORT WAS PLACED. PATIENT TOLERATED THE PROCEDURE WELL. PORT REPLACEMENT WAS SUCCESSFUL. PORT WAS REPLACED WITH A LOW-PROFILE POWER INJECTABLE SINGLE LUMEN PORT. DEFECTIVE PORT IS A BARD PORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228562 PORT-A-CATH PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR LJT BARD ACCESS SYSTEMS INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR