BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD POWERPORT

    MDR report key: 2201990 · Received August 5, 2011

    Report

    Report Number
    MW5021664
    Event Type
    Injury
    Date Received
    August 5, 2011
    Date of Event
    July 18, 2011
    Report Date
    August 5, 2011
    Manufacturer
    CR BARD
    Product Code
    LJT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT. WITH BEHCET'S SYNDROME WITH POOR VENOUS ACCESS HAD POWER PORT INSERTED (B)(6) 2010. PT. COMING IN DAILY BEGINNING (B)(6) 2011 FOR SOLUMEDROL INFUSIONS. ON (B)(6) 2011, SITE WAS ACCESSED AT 1015 AND 250 CC NS BEGUN AT 200CC/HR. A 250 MGM SOLUMEDROL ADDED. AT 1120, PT. C/O BURNING AND SWELLING AT PORT SITE. INFUSION STOPPED. SENT TO RADIOLOGY FOR PORT CHECK UNDER FLUORO. REVEALED THROMBOSED AND LEAKING PORT A CATH. UNABLE TO DETERMINE IF PIN HOLE LEAK OR CATHETER FRACTURE. RETURNED (B)(6) 2011 FOR PORT REMOVAL AND REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD POWERPORT PORT A CATH LJT CR BARD AP09114 REUA 1079

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention