BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUDENZ VALVE, 16MM, BURR HOLE, MEDIUM PRESSURE

    MDR report key: 7622338 · Received June 20, 2018

    Report

    Report Number
    2648988-2018-00028
    Event Type
    Malfunction
    Date Received
    June 20, 2018
    Date of Event
    March 28, 2018
    Report Date
    May 29, 2018
    Manufacturer
    INTEGRA NEUROSCIENCES PR
    Product Code
    JXG
    PMA / PMN Number
    K760502
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    FIVE (5) VALVES WERE RETURNED FOR EVALUATION. THE RMA DOCUMENTATION STATES THAT 5 VALVES FROM LOT 1173082 WERE RETURNED; NONETHELESS, COMPLAINT COMMUNICATION FORMS SUPPLIED REPORTED TWO (2) VALVES FOR LOT 1173082 AND THREE (3) FOR LOT 1173081. SINCE THE VALVES WERE NOT IN THE ORIGINAL PACKAGE AND ALL FIVE (5) WERE RETURNED INSIDE THE SAME PACKAGE, IT IS NOT POSSIBLE TO CONFIRM THE ASSOCIATED LOT NUMBER OF THE RETURNED VALVES. TWO (2) OF THE VALVES STILL HAD A CATHETER ATTACHED TO THEM (A SHORT VENTRICULAR ONE, AND AN OPEN-END ONE ABOUT 40.5 CM LONG); THE OTHERS DIDN¿T HAVE ANYTHING ATTACHED TO THEM. ALSO, A LOOSE CATHETER (ABOUT 1.2 METERS LONG) WAS INCLUDED IN THE PACKAGE. IT WAS PROCEEDED TO DETACH THE CATHETERS FROM THE VALVES. USING A SYRINGE, WATER WAS PASSED THROUGH THE CATHETERS TO ENSURE THE CATHETERS WERE NOT OCCLUDED. NO OBSTRUCTION WAS DETECTED IN THE CATHETERS. THE VALVES WERE VISUALLY INSPECTED AND NO ANOMALY WAS OBSERVED. THE 40.5 CM CATHETER PROVIDED WAS FILLED WITH WATER AND CONNECTED TO THE VALVES. THE ASSEMBLY WAS SET WITH THE VALVE AT THE BOTTOM AND WATER FLOWED INTO THE VALVE (THROUGH VALVE¿S DIAPHRAGM) BY GRAVITY IN 4 OUT OF 5 VALVES. SINCE NO WATER WENT INTO THE FIFTH VALVE, PRESSURE WAS APPLIED USING A SYRINGE AND AFTER CONSIDERABLE FORCE THE DIAPHRAGM ALLOWED FLOW. DHRS FOR FINISHED GOODS LOTS 1173081 AND 1173082, AND VALVE SUBASSEMBLIES 1172877 AND 1172878 WERE REVIEWED AND NO ANOMALY WAS OBSERVED THAT COULD HAVE CAUSED THE REPORTED CONDITION. THE COMPLAINT IS CONFIRMED AS ¿NO LIQUID PASSING THROUGH THE VALVE¿. THERE ARE CONTROLS/TESTS IN PLACE TO AVOID THIS TYPE OF EVENTS ¿ 100% OF THE VALVES ARE TESTED DURING THE MANUFACTURING. THERE ARE SEVERAL STATEMENTS IN THE IFU WHICH INSTRUCT TO VERIFY FLUID FLOW THROUGH THE VALVE PRIOR IMPLANTATION. THIS IS TO ENSURE VALVE¿S PROPER PERFORMANCE AS SILICONE TENDS TO STICK TO ITSELF WHEN DRY. DEVICE IDENTIFIER: (B)(4).

    Description of Event or Problem · 0

    N/A.

    Additional Manufacturer Narrative · 1

    THE DEVICES WERE NOT YET RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE PLANT INVESTIGATION IS IN PROGRESS AND A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION. LINKED TO MFG. REPORT NUMBERS: 2648988-2018-00029 AND 2648988-2018-00030.

    Additional Manufacturer Narrative · 1

    NO FAILURE ANALYSIS CAN BE PERFORMED SINCE THE UNITS HAVE NOT BEEN RECEIVED FOR EVALUATION. DHRS FOR FINISHED GOODS LOTS 1173081 AND 1173082, AND VALVE SUBASSEMBLIES 1172877 AND 1172878 COMPLIED WITH ALL IN-PROCESS INSPECTIONS AND TESTING REQUIREMENTS AS SPECIFIED IN THE MANUFACTURING SHOP ORDER AND RELATED PROCEDURES. AT THE MOMENT, THE COMPLAINT IS CONSIDERED UNCONFIRMED. THE ROOT CAUSE FOR THIS EVENT IS UNDETERMINED.

    Description of Event or Problem · 1

    THIS IS THE FIRST OF THREE REPORTS. A DISTRIBUTOR REPORTED ON BEHALF OF THE CUSTOMER THAT NO LIQUID WAS PASSING THROUGH THE NL8501356 PUDENZ VALVE ON (B)(6) 2018. THERE WAS NO INJURY REPORTED ON THE (B)(6) PATIENT. THERE WAS A 20 MINUTE DELAY IN SURGERY DUE TO THE PRODUCT PROBLEM. ADDITIONAL INFORMATION WAS RECEIVED ON 11JUN2018 STATING THAT ONE (1) PUDENZ VALVE WITH LOT NUMBER 1173082 AND THREE (3) PUDENZ VALVES WITH LOT NUMBER 1173081 DID NOT FUNCTION DURING THE SAME SURGERY/PROCEDURE ON THIS SAME PATIENT. THERE WAS A DELAY IN SURGERY BUT NO HARM TO THE PATIENT OCCURRED. REPLACEMENT UNITS WERE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460311 PUDENZ VALVE, 16MM, BURR HOLE, MEDIUM PRESSURE N/A JXG INTEGRA NEUROSCIENCES PR 1173082

    Patients

    Seq Age Sex Outcome Treatment
    1 3 MO