BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GROSHONG 4 FR PICC

    MDR report key: 190160 · Received October 1, 1998

    Report

    Report Number
    1720496-1998-00307
    Event Type
    Malfunction
    Date Received
    October 1, 1998
    Report Date
    September 3, 1998
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    DQO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING PLACEMENT, AFTER REMOVAL OF STYLET, THEY GOT BLOOD BACK FROM THE CATHETER. REMOVED CATHETER AND REPLACED "OTG". AFTER REMOVAL, THEY NOTICED A SMALL PIECE OF GUIDEWIRE PROTRUDING THROUGH THE VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GROSHONG 4 FR PICC LONG TERM INTRAVASCULAR CATHETER DQO BARD ACCESS SYSTEMS * 36EI7752

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention