BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    14F X 24CM SPLIT STREAM

    MDR report key: 2972019 · Received February 15, 2013

    Report

    Report Number
    2518902-2013-00007
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    January 10, 2013
    Report Date
    February 15, 2013
    Manufacturer
    MEDCOMP
    Product Code
    MSD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE SPLIT STREAM CATHETER WAS RETURNED FOR EVALUATION. A REVIEW OF THE MANUFACTURING RECORDS INDICATED ALL DEVICE SPECIFICATIONS AND QUALITY REQUIREMENTS WERE SATISFIED. A VISUAL EXAMINATION OF THE DEVICE REVEALED THAT THE LUMEN IS CUT 10CM FROM THE BOTTOM OF THE EXTENSION COLLARS. THE PRINTING ON THE LUMEN ARMS IS BARELY VISIBLE. CLOSER EVALUATION OF THE DEVICE REVEALED THAT THERE IS A CRACK ON THE EDGE OF THE VENOUS LUMEN AND ON THE EDGE OF THE ARTERIAL LUMEN AT THE END OF THE BONDED SECTION. THIS TYPE OF DAMAGE IS INDICATIVE OF STRESS BEING APPLIED TO THE CATHETER, EITHER FROM FORCEFUL MANIPULATION OR IMPROPER SECUREMENT. THE INCIDENT REPORT NOTED THAT THE DEVICE WAS IMPLANTED AND FUNCTIONED WITHOUT INCIDENT FOR 12 MONTHS. THE INCIDENT REPORT ALSO NOTED THAT THE FACILITY USED AN ACETONE BASED ADHESIVE REMOVAL PRODUCT AROUND THE EXIT SITE. MEDCOMP DOES NOT RECOMMEND THE USE OF ACETONE ON ANY OF OUR PRODUCTS. PRODUCTS HARSH ENOUGH TO REMOVE THE PRINTING/INK FROM THE CATHETER MAY AFFECT THE INTEGRITY OF THE LUMEN. WERE ARE UNABLE TO DETERMINE THE EXACT CAUSE OF THIS EVENT HOWEVER THE HANDLING OF THE DEVICE AND USE OF ACETONE MAY HAVE CONTRIBUTED TO THE DEVELOPMENT OF THE CRACK.

    Description of Event or Problem · 1

    AFTER REMOVING DRESSING A LEAKAGE OF BLOOD, FROM JUNCTION BETWEEN CATHETER BRANCHES, WAS NOTICED. A CLOSE LOOK SHOWED A SMALL RUPTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69689 14F X 24CM SPLIT STREAM HEMODIALYSIS CATHETER MSD MEDCOMP SST24E MBHA890

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention