BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWERLINE PICC

    MDR report key: 3934620 · Received June 26, 2014

    Report

    Report Number
    3006260740-2014-00325
    Event Type
    Injury
    Date Received
    June 26, 2014
    Report Date
    June 6, 2014
    Manufacturer
    BARD ACCESS SYSTEMS INC.
    Product Code
    LJS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MFR FOR EVAL, AS THE DEVICE REMAINS IN THE PT. A LOT HISTORY REVIEW (LHR) REVIEW IS NOT POSSIBLE, AS NO MFG LOT NUMBER HAS BEEN PROVIDED BY THE COMPLAINANT.

    Description of Event or Problem · 1

    ON (B)(6) 2014 - THE (B)(6) YEAR OLD PT IS A CKD STAGE IV WITH THIS LINE BEING PLACED AS A LAST DITCH ACCESS DEVICE. WITHIN 48-72 HOURS ONE PORT WAS CLOTTED AND UNABLE TO BE OPENED WITH ALTEPLASE. THIS CHILD WAS DISCHARGED AND AT HOME FOR ABOUT A WEEK. PRESENTED FRIDAY (B)(6) 2014 IN OUR PEDIATRIC ED WITH A HISTORY OF SHORTNESS OF BREATH AND CHEST PAIN. ECHO SHOWED AN ATRIAL CLOT. ON (B)(6) 2014 - THE PT IS BEING TREATED WITH CONTINUOUS ANTICOAGULATION THERAPY AND THEY ARE TRYING TO BRIDGE HER TO GO HOME ON COUMADIN. THE LINE IS FLUSHED WITH SALINE ONLY, AT LEAST EVERY 12 HOURS AND EACH TIME THE LINE IS USED FOR IV INFUSION. ONE LUMEN BECAME CLOTTED AND THEY WERE INITIALLY UNABLE TO CLEAR THE LINE WITH ALTEPLASE. FACILITY REPORTED THE LUMEN IS NOW CLEAR. THE OTHER LUMEN HAS NOT HAD ANY ISSUES. PT IS NOT GETTING DIALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    372921 POWERLINE PICC PERCUTANEOUS IMPLANTED LONG TERM CATHETER LJS BARD ACCESS SYSTEMS INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention