BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4FR PICC BASIC TRAY

    MDR report key: 4102727 · Received August 28, 2014

    Report

    Report Number
    3006260740-2014-00437
    Event Type
    Malfunction
    Date Received
    August 28, 2014
    Date of Event
    February 26, 2014
    Report Date
    February 26, 2014
    Manufacturer
    BARD ACCESS SYSTEMS INC.
    Product Code
    DQY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLIANT OF INABILITY TO ASPIRATE WAS CONFIRMED AND FOUND TO BE USE-RELATED. THE RETURNED PRODUCT WAS ONE 4FR S/L GROSHONG PICC. THE STYLET WAS STILL INLAID WITHIN THE CATHETER AND THE SAMPLE WAS FREE OF RESIDUE. AN ATTEMPT TO INFUSE AND ASPIRATE WATER THROUGH THE CATHETER REVEALED WATER ASPIRATION WITH AN AIR LEAK, AND A SPRAYING LEAK WAS FOUND AT THE 46CM DEPTH MARKING. MICROSCOPIC EXAMINATION OF THE LEAK SITE REVEALED A SMALL IRREGULAR SPLIT. WHEN THE STYLET WAS REMOVED AND THE CATHETER SPLIT LONGITUDINALLY, THE INTERIOR OF THE CATHETER EXHIBITED INTERMITTENT IMPRESSIONS TYPICAL OF STYLET DAMAGE. TACTILE EVALUATION OF THE CATHETER WAS UNREMARKABLE. THE DAMAGE FOUND AT THE LEAK SITE WAS TYPICAL OF STYLET DAMAGE BY THE USER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT NO BACK FLOW IN PICCLINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    526744 4FR PICC BASIC TRAY DQY BARD ACCESS SYSTEMS INC. REW11275

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention