BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVILYST MEDICAL

    MDR report key: 4860137 · Received June 19, 2015

    Report

    Report Number
    1317056-2015-00128
    Event Type
    Injury
    Date Received
    June 19, 2015
    Date of Event
    May 20, 2015
    Report Date
    May 22, 2015
    Manufacturer
    NAVILYST MEDICAL
    Product Code
    LJS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED FOR THE REPORTED PACKAGING LOT FOR ANY DEVIATIONS RELATED TO THE REPORTED EFFECT OF THE COMPLAINT. THE REVIEW CONFIRMS THAT THE LOT MET ALL MATERIAL, ASSEMBLY, AND PERFORMANCE SPECIFICATIONS. THE NAVILYST MEDICAL MAY 2015 COMPLAINT REPORT WAS REVIEWED FOR THE PRODUCT FAMILY OF STOPCOCKS/MANIFOLDS AND THE FAILURE MODE "END USER INJURED BY MANIFOLD." NO ADVERSE TRENDS WERE IDENTIFIED, NOR HAS ANY COMPLAINT REGARDING HANDLE FLASH AND END USER INJURY BEEN REPORTED WITHIN THE PAST 5 YEARS. THE RETURNED MANIFOLD HANDLE WAS VISUALLY INSPECTED AND THE PRESENCE OF FIRMLY AFFIXED FLASH ON THE STAR-SHAPED HANDLES WAS CONFIRMED. THE FLASH WAS MEASURED AND FOUND TO BE LESS THAN 0.022". THE SPECIFICATION FOR ALLOWABLE FIRMLY AFFIXED FLASH IS "NOT GREATER THAN 0.040". THE FINGER OF A NITRILE RUBBER GLOVE WAS PUSHED DOWN AND AGAINST THE FLASH ON EACH HANDLE AND NO CUT OR PUNCTURE OCCURRED, I.E., THE REPORTED EVENT COULD NOT BE DUPLICATED. RETAINED MANIFOLD HANDLE SAMPLES WERE ALSO SIMILARLY EXAMINED AND TESTED WITH A NITRILE RUBBER GLOVE AND THE GLOVE WAS NOT PUNCTURED OR DAMAGED. THE ROOT CAUSE OF THE FLASH OBSERVED ON THE STAR-SHAPED HANDLES IS TOOLING WEAR OCCURRING ON THE PARTING LINE AND BETWEEN THE INSERTS OF THE MOLD. THE FLASH LENGTH IS WITHIN ACCEPTABLE SPECIFICATION LENGTH AND CUTTING/PUNCTURING OF A GLOVE COULD NOT BE DUPLICATED. AS NO SIMILAR COMPLAINTS HAVE BEEN REPORTED, THE ISSUE EXPERIENCED BY THE END USER IS DEEMED TO HAVE BEEN AN ISOLATED INCIDENT. NO CORRECTION IS REQUIRED SINCE THE HANDLE FLASH WAS DETERMINED TO MEET DIMENSIONAL SPECIFICATION AND CUTTING/PUNCTURE OF A PLASTIC GLOVE COULD NOT BE DUPLICATED IN EITHER THE ACTUAL COMPLAINT SAMPLE OR THE HANDLE RETAINS. THE MOLDING ENGINEERING DEPT HAS, HOWEVER, IDENTIFIED A CORRECTIVE ACTION THAT MAY MINIMIZE THIS FLASH ISSUE GOING FORWARD. THE MOLD TOOLING WILL BE SENT OUT FOR REPAIR TO ADDRESS THE TOOLING WEAR, WHICH WILL MINIMIZE SIZE AND SHAPE OF THE FLASH. PROCESS CONTROLS ON THE MANIFOLD CURRENTLY INCLUDE VISUAL AND DIMENSIONAL INSPECTIONS, USING A MICROSCOPE ON THE MANIFOLD HANDLES FOR MOLDING DEFECTS. THESE INSPECTIONS INCLUDE, BUT ARE NOT LIMITED TO, VISUALIZING FOR KNIT LINES, DRAG LINES, CRACKS, SCRATCHES, INCOMPLETE MOLDS, AND DAMAGE. ADDITIONAL INSPECTIONS FOR FLASH, AND OTHER MOLDING DEFECTS ARE PERFORMED ON THE ASSEMBLED MANIFOLD DEVICES. (B)(4).

    Description of Event or Problem · 1

    AS REPORTED BY NAVILYST MEDICAL'S DISTRIBUTOR IN (B)(4), DURING A PROCEDURE UTILIZING A CONVENIENCE KIT, FLASH ON THE MANIFOLD HANDLE PUNCTURED THE PHYSICIAN'S GLOVE AND RESULTED IN BLEEDING. THE USED MANIFOLD WAS RETURNED TO NAVILYST MEDICAL FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401358 NAVILYST MEDICAL CONVENIENCE KIT LJS NAVILYST MEDICAL 4817651

    Patients

    Seq Age Sex Outcome Treatment
    1