BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AHMED GLAUCOMA VALVE

    MDR report key: 3035883 · Received January 2, 2013

    Report

    Report Number
    1000125279-2012-00005
    Event Type
    Malfunction
    Date Received
    January 2, 2013
    Report Date
    December 31, 2012
    Manufacturer
    NEW WORLD MEDICAL, INC.
    Product Code
    KYF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION REPORT: VALVE WAS INSPECTED UNDER A MICROSCOPE AT 10X MAGNIFICATION. NO PHYSICAL DAMAGE WAS OBSERVED, BUT VALUE WAS COVERED WITH BLOOD. AFTER CLEANING THE VALVE WITH ALCOHOL, IT WAS LEFT TO DRY FOR 2 HOURS. VALVE WAS PRIMED USING THE IMPLANT PREPARATION INSTRUCTIONS, AND IT WAS FOUND TO BE IN GOOD WORKING CONDITION. FLOW TEST WAS PERFORMED TO ASSURE VALVE WAS WORKING PROPERLY. RESULTS ARE AS FOLLOWS: THE FLOW TEST STARTED AT 13.0 INCHES OF WATER. AT 6.7 INCHES OF WATER (12.5 MM HG) THE VALVE CLOSED. THE ACCEPTANCE CRITERIA IS 90 MICROLITER/MINUTE OR LESS AT 5 INCHES OF WATER (9.3 MMHG). THE DEVICE IS WITHIN THE SPECIFIED RANGE. THE DEVICE HISTORY FILE FOR THIS LOT WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. CONCLUSION: THE VALVE WAS FOUND TO BE IN GOOD WORKING CONDITION, THE CUSTOMER REPORT INDICATED THAT THE LIQUID WAS NOT FLOWING, THIS COULD NOT BE DEMONSTRATED. THE RESULTS FROM THE EVALUATION INDICATE THAT THE VALVE IS CONTROLLING THE FLUID FLOW AT A SAFE LEVEL.

    Description of Event or Problem · 1

    VALVE WAS IMPLANTED, AND EXPLANTED BECAUSE LIQUID WAS NOT FLOWING. ON (B)(6) 2012, WE RECEIVED A CALL FROM A CUSTOMER INDICATING THAT THEY WANTED TO RETURN A VALVE THAT WAS IMPLANTED AND EXPLANTED BECAUSE LIQUID WAS NOT FLOWING. THE PRODUCT WAS RECEIVED ON (B)(6) 2012 AT NEW WORLD MEDICAL, INC.'S FACILITY INSIDE A CONTAINER IN A PLASTIC BAG WITH THE MODEL NUMBER, SERIAL NUMBER AND LOT NUMBER. ON (B)(6) 2012 CUSTOMER WAS CONTACTED TO OBTAIN IMPLANT AND EXPLANT DATES. IN THE CONVERSATION IT WAS MENTIONED THAT IT WERE NO COMPLICATIONS AND THE PATIENT WAS DOING WELL. UNTIL TODAY THE IMPLANT AND EXPLANT DATES INFORMATION HAS NOT BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2202 AHMED GLAUCOMA VALVE GLAUCOMA SHUNT KYF NEW WORLD MEDICAL, INC. FP7 F0112

    Patients

    Seq Age Sex Outcome Treatment
    1