BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HICKMAN DIALYSIS/APHERESIS 13.5 FR. CHRONIC DUAL LUMEN CATHE

    MDR report key: 1882074 · Received October 8, 2010

    Report

    Report Number
    3006260740-2010-00287
    Event Type
    Malfunction
    Date Received
    October 8, 2010
    Date of Event
    September 15, 2010
    Report Date
    September 20, 2010
    Manufacturer
    C. R. BARD INC. (BASD)
    Product Code
    LJS
    PMA / PMN Number
    K830233
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT IS CONFIRMED, USER RELATED. VISUAL EXAMINATION OF THE RETURNED CHRONIC CATHETER NOTED A 0.6 INCH LONGITUDINAL SPLIT IN THE DISTAL EXTENSION LEG JUST BEFORE THE BIFURCATION. THE SPLIT HAS CURVED EDGES AND A 0.1 INCH PROTRUDED SECTION LOCATED IN THE MIDDLE. MICROSCOPIC EXAMINATION OF THE SPLIT CROSS SECTION NOTED THE SURFACE TO BE DULL AND GRANULAR IN APPEARANCE. THE PROTRUSION IS ROUGH AND UNEVEN. THE SAMPLE WAS FLUSHED WITH WATER USING A 12CC SYRINGE. BOTH LUMENS WERE PATENT TO INFUSION BUT LEAKING OCCURRED DUE TO THE LARGE SPLIT IN THE "DISTAL" EXTENSION LEG LUMEN. THE PRODUCT IFU STATES: "INFUSION PRESSURE GREATER THAN 25 PSI (172 KPA) MAY DAMAGE BLOOD VESSELS AND VISCOUS AND IS NOT RECOMMENDED. DO NOT USE A SYRINGE SMALLER THAN 10 ML!" THIS IS A USER MAINTENANCE ISSUE. A CHR OF LOT# REUD0526 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINTS FROM THIS LOT NUMBER.

    Description of Event or Problem · 1

    THE CATHETER WAS HAND INJECTED WITH OMNISCAN CT CONTRAST USING A 20CC SYRINGE ATTACHED TO CT EXTENSION TUBING. THE CATHETER WAS THEN IMMEDIATELY FLUSHED WITH 10CC NORMAL SALINE. DURING THE SALINE HAND INJECTION FLUSH THE TECH HEARD A "POP" AND NOTICED THE EXTENSION LEG ON THE HICKMAN CATHETER JUST ABOVE THE BIFURCATION HAD BURST AND SPLIT ABOUT A 3/4" LONG SPLIT LENGTHWISE ON THE EXTENSION LEG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HICKMAN DIALYSIS/APHERESIS 13.5 FR. CHRONIC DUAL LUMEN CATHE LJS C. R. BARD INC. (BASD) REUD0526

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention