BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AHMED GLAUCOMA VALVE

    MDR report key: 8701940 · Received June 14, 2019

    Report

    Report Number
    1000125279-2019-00047
    Event Type
    Malfunction
    Date Received
    June 14, 2019
    Report Date
    May 22, 2019
    Manufacturer
    NEW WORLD MEDICAL, INC
    Product Code
    KYF
    UDI-DI
    00892064002119
    PMA / PMN Number
    K162060
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2019, HEALTH (B)(6) CONTACTED NEW WORLD MEDICAL FOR A MANDATORY RESPONSE ON THE FOLLOWING COMPLAINT: "AHMED VALVE NO (NOT READABLE) TO IRRIGATION WITH BSS. A (NOT READABLE) IS REQUIRED OR ELSE THE (NOT READABLE) WOULD BE TOO LOW. SUSPECTED VALVE (NOT READABLE) MALFUNCTION". THE LOT NUMBER REPORTED WAS LOT N0918. NWM DISTRIBUTOR, (B)(6) OPHTHALMICS, WAS CONTACTED TO DETERMINE WHETHER THE EVENT REPORTED BY HEALTH (B)(6) HAD BEEN ALREADY REPORTED TO NEW WORLD MEDICAL. THE DISTRIBUTOR STATED THAT THE COMPLAINT WAS LINKED TO THEIR PRODUCT INCIDENT REPORT FOR "THE CUSTOMER REPORTED THAT THERE WAS DIFFICULTY WHEN PRIMING THE VALVES". THE DEVICE HISTORY RECORD WAS REVIEWED FOR COMPLIANCE AND NO ISSUES WERE OBSERVED. PRODUCT WAS MANUFACTURED, TESTED, AND RELEASED IN COMPLIANCE WITH OUR PROCEDURES. THE RETURNED VALVES WERE TESTED PER NWM PROCEDURES AND COULD PERFORM AS EXPECTED. THE AMOUNT OF PRESSURE APPLIED DURING PRIMING WILL NOT AFFECT THE VALVE'S FUNCTION. THERE WERE NO PATIENT OR USER INJURIES INVOLVED WITH THE USE OF THE DEVICES REPORTED.

    Description of Event or Problem · 1

    AHMED VALVE NO (NOT READABLE) TO IRRIGATION WITH BSS. A (NOT READABLE) IS REQUIRED OR ELSE THE (NOT READABLE) WOULD BE TOO LOW. SUSPECTED VALVE (NOT READABLE) MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    494543 AHMED GLAUCOMA VALVE GLAUCOMA SHUNT KYF NEW WORLD MEDICAL, INC FP7 N0918 00892064002119

    Patients

    Seq Age Sex Outcome Treatment
    1 Other