BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD ACCESS SYSTEMS

    MDR report key: 409325 · Received July 31, 2002

    Report

    Report Number
    MW1025779
    Event Type
    Malfunction
    Date Received
    July 31, 2002
    Date of Event
    July 2, 2002
    Report Date
    July 30, 2002
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    USING A BARD ACCESS SYSTEMS 5 FR SAFETY PICC EXCALIBER INTRODUCER, AFTER ACCESSING VEIN AND REMOVING STYLET, THE BLUNTING TIP CAME OUT PROPERLY BUT THE SHARP STYLET PORTION HAD BECOME DETACHED FROM THE PLASTIC HOUSING OF DEVICE AND WAS STILL IN THE PT. ABLE TO GRASP AND REMOVE WITHOUT PT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD ACCESS SYSTEMS 5FR PICC INTRODUCER/EXCALIBUR DYB BARD ACCESS SYSTEMS * 22EM9019

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other