BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3FR GROSHONG SINGLE LUMEN

    MDR report key: 805216 · Received January 12, 2007

    Report

    Report Number
    MW1041607
    Event Type
    Malfunction
    Date Received
    January 12, 2007
    Manufacturer
    BARD
    Product Code
    LJS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AK, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A #3FR GROSHONG PICC LOT #REQC0586 PLACED IN PT IN R POPLITEAL VEIN USING MODIFIED SELDINGER TECHNIQUE AND SITE RITE ULTRASOUND. PICC HAD A GOOD BLOOD DRAW FOR THE FIRST 24-36 HRS THAN STAFF RN'S UNABLE TO DRAW BLOOD. ABLE TO FLUSH PICC, JUST NOT ABLE TO WITHDRAW. PT NEEDED MORE ACCESS AND THIS PICC WAS REMOVED AND A DUAL LUMEN PER-Q-CATH PLACED. BARD REP NOTIFIED OF POSSIBLE PROBLEM AND HE HAD SR. FIELD ASSURANCE REP FOR BARD ACCESS SYSTEMS CONTACT ME. BARD OPENED UP A FILE AND ASSIGNED CASE NUMBER TO THIS ITEM. BARD WISHES FOR US TO SHIP THE ITEM BACK TO THEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3FR GROSHONG SINGLE LUMEN PICC LJS BARD * REQC0586

    Patients

    Seq Age Sex Outcome Treatment
    1 *