BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENTRICULAR CATHETER ACCESSORY KIT (VCAK)

    MDR report key: 3126752 · Received May 20, 2013

    Report

    Report Number
    9612007-2013-00014
    Event Type
    Injury
    Date Received
    May 20, 2013
    Report Date
    May 20, 2013
    Manufacturer
    INTEGRA NEUROSCIENCES IMPLANTS S.A.
    Product Code
    JXG
    PMA / PMN Number
    K914995
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT EXPECTED TO BE RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    THE SECOND REPORT OF TWO INVOLVING THE SAME PATIENT. AN INQUIRY WAS MADE BY A NURSE SPECIALIST FROM THE (B)(6) THAT INVOLVED A PATIENT WHO HAS A 951-303 VENTRICULAR CATHETER (VCAK) AND INS8301 HERMETIC PLUS SYSTEM IN PLACE. THE PATIENT HAD THREE (3) POSITIVE (CSF) CEREBROSPINAL FLUID CULTURES FOR BETA-D-GLUCAN, AN ASSAY FOR FUNGAL INFECTIONS. THIS ASSAY CAN DISPLAY MANY FALSE POSITIVE RESULTS DUE TO THE PRESENCE OF CELLULOSE, AND THE CUSTOMER WANTED TO RULE OUT THAT OUR PRODUCTS CONTAIN CELLULOSE. OUR MANUFACTURER CONFIRMED THAT NEITHER PRODUCT HAS ANY CELLULOSE IN THE CSF FLOW PATHWAY. THE CUSTOMER WAS PROVIDED THE MANUFACTURER'S INFO AND SHE CONFIRMED THAT PATIENT IS NOT ON DIALYSIS, NOR ON ANY ANTIBIOTICS THAT ARE KNOWN TO CAUSE FALSE POSITIVE RESULT, AND HAS NOT RECEIVED ALBUMIN OR OTHER BLOOD PRODUCTS (ALL VARIABLES THAT CAN CAUSE FALSE POSITIVE RESULTS). UPON REQUEST FOR FURTHER INFO THE CLINICIAN REFUSED TO PROVIDE ANY FURTHER INFO REGARDING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222887 VENTRICULAR CATHETER ACCESSORY KIT (VCAK) EXTERNAL DRAINAGE ACCESSORIES JXG INTEGRA NEUROSCIENCES IMPLANTS S.A.

    Patients

    Seq Age Sex Outcome Treatment
    1