BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARDPORT

    MDR report key: 1328525 · Received February 27, 2009

    Report

    Report Number
    1328525
    Event Type
    Malfunction
    Date Received
    February 27, 2009
    Date of Event
    February 6, 2009
    Report Date
    February 24, 2009
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    LJT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IA, US

    Narratives

    Description of Event or Problem · 1

    A PATIENT BEGAN EXPERIENCING DISCOMFORT UPON PORT FLUSHING ALONG WITH LEFT ARM PAIN, ALTHOUGH THERE WAS STILL GOOD BLOOD RETURN. A LINE STUDY DETERMINED THE PORT WAS LEAKING AND A DECISION WAS MADE TO SURGICALLY REMOVE IT. UPON REMOVAL, FOUR SMALL HOLES WERE FOUND ON THE BACK OF PORT SEPTUM; THE RUBBER SIDE APPEARED TO BE INTACT.====================== MANUFACTURER RESPONSE FOR PORT, BARDPORT IMPLANTED PORT 6.6 FRENCH LOW PROFILE======================STAFF WAS PROVIDED WITH RESPONSE "PLEASE CALL FIELD ASSURANCE ABOUT THE ISSUE WITH THE PORT. 1-801-595-0700 EXTENSION 4."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARDPORT PORT, VASCULAR ACCESS LJT BARD ACCESS SYSTEMS 6.6 FRENCH LOW PROFILE RERK0770

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR