BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD ACCESS SYSTEMS

    MDR report key: 2469561 · Received February 16, 2012

    Report

    Report Number
    2469561
    Event Type
    Malfunction
    Date Received
    February 16, 2012
    Date of Event
    November 8, 2011
    Report Date
    February 3, 2012
    Manufacturer
    BARD ACCESS SYSTMES
    Product Code
    LJS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US

    Narratives

    Description of Event or Problem · 1

    INSERTED PURPLE PICC WITH STYLET INTO THE INTRODUCER. SHERLOCK WAS ACTIVATED; SHERLOCK INDICATOR WENT ACROSS SCREEN INSTEAD OF DROPPING DOWN WHEN PICC IS IN CORRECT PLACE, PULLED PICC AND WIRE BACK TOGETHER NOT COMING OUT OF THE SHEATH. ADVANCED PICC AND WIRE WATCHING SHERLOCK FOR APPROPRIATE PLACEMENT, REPEATED THIS AGAIN. SHERLOCK INDICATOR STILL MOVING ACROSS SCREEN INSTEAD OF DROPPING DOWN. ATTEMPTED TO REMOVE ENTIRE PICC AND STYLET, THE FEELING WAS THAT THE VEIN WAS SPASM. PICC REMAINED IN PLACE AND THE WIRE WAS REMOVED. EXAMINED THE STYLET, THE TIP WAS CURVED. THE RIGHT SHOULDER X-RAY CONFIRMED APPROPRIATE PICC PLACEMENT, BUT OBSERVED A SHINY AREA ALONG PICC. PT TO SPECIALS FOR FOREIGN BODY REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD ACCESS SYSTEMS PICC - SOLO CATH 4 F LJS BARD ACCESS SYSTMES 9194108D *

    Patients

    Seq Age Sex Outcome Treatment
    1 *