BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD

    MDR report key: 2220451 · Received August 17, 2011

    Report

    Report Number
    MW5021808
    Event Type
    Injury
    Date Received
    August 17, 2011
    Date of Event
    August 5, 2010
    Report Date
    August 17, 2011
    Manufacturer
    BARD ACCESS SYSTEMS INC.
    Product Code
    LJT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    BARD POWER PORT WITH GROSHONG CATHETER LIFE THREATENING EVENT. CATHETER SEPARATION FROM PORT SLIPPED INTO BLOODSTREAM AND ENTERED MY HEART. REASON FOR USE: CROHN'S DISEASE, HYPERTENSION, ENDOCRINOLOGICAL ORTHOSTASIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD POWER PORT IMPLANTABLE PORT DEVICE WITH GROSHONG CATHETER LJT BARD ACCESS SYSTEMS INC. REUB0513

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Life Threatening| S DAILY IV INFUSION FOR CHRONIC ACUTE DEHYDRATION