BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUDENZ VALVE, 16MM, BURR HOLE, MEDIUM PRESSURE

    MDR report key: 6475226 · Received April 10, 2017

    Report

    Report Number
    2648988-2017-00008
    Event Type
    Malfunction
    Date Received
    April 10, 2017
    Report Date
    March 21, 2017
    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 · 1

    INVESTIGATION COMPLETED 5/18/2017. ONE (1) BAG WAS RECEIVED CONTAINING THREE (3) VALVES; THEREFORE, IT IS NOT POSSIBLE TO IDENTIFY THE LOT NUMBER OF THE VALVES FOR EACH COMPLAINT. THE VALVES RECEIVED ARE PART OF THE FOLLOWING THREE (3) COMPLAINTS: COMPLAINT NUMBER / REPORTED LOT NUMBER / CATALOG NUMBER: 163584 / 1161140 / NL8501356, 163587 / 1154399 / NL8501356, 165104 / 1161781 / NL8501356. THE VALVES WERE VISUALLY INSPECTED AND ALL THREE (3) WERE IN GOOD CONDITION. A VERIFICATION OF PATENCY WAS PERFORMED USING A SYRINGE AND COLORED WATER. WATER WAS PASSED THROUGH THE VALVE USING A SYRINGE AND A CONNECTOR TO ATTACH TO THE VALVES¿ INLET (REFER TO PHOTOS IN ATTACHMENT I). RESULTS: VALVE NUMBER / OBSERVATIONS: 1 / WATER PASSED THROUGH THE VALVE WITHOUT ANY RESISTANCE. 2 / WATER PASSED THROUGH THE VALVE. THERE WAS SOME INITIAL RESISTANCE AND SOME PRESSURE HAD TO BE EXERTED TO GET THE INITIAL FLOW. ONCE THE VALVE COMPONENTS WERE WET, WATER FLOWED AS EXPECTED. 3 / WATER PASSED THROUGH THE VALVE. THERE WAS SOME INITIAL RESISTANCE AND SOME PRESSURE HAD TO BE EXERTED TO GET THE INITIAL FLOW. ONCE THE VALVE COMPONENTS WERE WET, WATER FLOWED AS EXPECTED. DEVICE HISTORY RECORDS (DHRS) OF THE FINISH GOODS LOT #S 1161140 AND 1154399 WERE REVIEWED TO DETECT ANY ANOMALIES THAT COULD HAVE OCCURRED DURING THE PRODUCTS¿ MANUFACTURING PROCESS WHICH COULD HAVE CONTRIBUTED AND/OR BE RELATED WITH THE REPORTED CONDITION UNDER INVESTIGATION. PACKAGED LOT NUMBER: 1161140 / 1154399. CATALOG NUMBER: NL850-1356 / NL850-1356. DEVICE IDENTIFIER: (01)10381780071457 / (01)10381780071457. PRODUCT IDENTIFIER: (17)210430(10)1161140 / (17)201231(10)1154399. MANUFACTURING (PACK) DATE: 4/30/16 / 12/15/15. RELEASED FOR DISTRIBUTION: 5/11/16 / 01/08/1.6 EXPIRATION DATE: 04/30/2021 / 12/31/2020. THE NON -STERILE PUDENZ VALVES 16MM, MEDIUM PRESSURE PACKAGED IN THE ABOVE-MENTIONED LOTS WERE: PACKAGED LOT NUMBER: 1161140 / 1154399. VALVE PART NUMBER: 600784-005 / 600784-005. VALVE LOT NUMBER: 1161235 & 1161401 / 1153796 & 1153797. NON-STERILE VALVES SHOP ORDERS WERE REVIEWED. ALL UNITS WERE TESTED BY MANUFACTURING PERSONNEL FOR OCCLUSION, LEAKAGE, BACKFLOW, AND PRESSURE LEAKAGE AS PER TM-152 (LEAKAGE TESTING OF VALVES AND CATHETERS), TM-153 (BACKFLOW TESTING OF VALVES), TM-0171 (FLOW PRESSURE TEST WITH TRANSDUCER), AND DRWG-60784 (PUDENZ VALVE WITH INTEGRAL CONNECTOR). ALSO, QA PERFORMED AQL VERIFICATIONS THROUGHOUT THE PROCESS TO VERIFY PRODUCT QUALITY. NO ANOMALY OR DISCREPANCIES WERE REPORTED DURING THE MANUFACTURING OR PACKAGING OF THE FG LOTS THAT COULD BE RELATED TO THE REPORTED CONDITION. NO RELATED NCR, CAPA, OR SCAR WAS OPENED DURING THE PERIOD OF FEBRUARY 2015 TO FEBRUARY 2017. UPON REVIEW OF INTEGRA'S COMPLAINT SYSTEM FROM MARCH 2015 - MARCH 2017, THERE HAVE BEEN THREE (3) COMPLAINTS RELATED TO NO FLOW FOR THE PUDENZ PRODUCT FAMILY (INCLUDING THESE TWO). APPROXIMATELY (B)(4) UNITS HAVE BEEN RELEASED FOR DISTRIBUTION FROM MARCH 2015 ¿ MARCH 2017, RESULTING IN A COMPLAINT OCCURRENCE RATE OF APPROXIMATELY (B)(4). DOCUMENTATION REVIEW OF THE VALVES SHOWED THAT THE MANUFACTURING AND PACKAGING PROCESSES RAN NORMALLY. THERE ARE NO INDICATIONS THAT THE REPORTED COMPLAINTS WERE AS RESULT OF THESE PROCESSES. ALL VALVES ARE TESTED FOR OCCLUSION, LEAKAGE, BACKFLOW, AND FLOW PRESSURE DURING MANUFACTURING AND ALL RELEASED VALVES MEET ALL THE ESTABLISHED REQUIREMENTS. APPARENTLY, THE INTERNAL COMPONENTS OF THE VALVE HAD STUCK TOGETHER AND REQUIRED SOME PRESSURE TO BE APPLIED TO GET FLUID FLOW STARTED. AS SPECIFIED IN THE IFU: ¿THIS DEVICE IS MADE OF SILICONE RUBBER, WHICH LIKE MOST RUBBER, MAY STICK TO ITSELF WHEN DRY. THIS TENDENCY TO STICK MAY RESULT IN SLIGHT VALVE PERFORMANCE VARIATIONS WHICH MAY DIFFER FROM LABEL SPECIFICATIONS. WHEN WET, THE SILICONE RUBBER SHOULD NOT STICK, THEREFORE, THE SURGEON MUST VERIFY THAT THE VALVE COMPONENTS ARE WET AND THAT FLUID FLOWS FREELY THROUGH THE VALVE.¿ THE COMPLAINT IS CONSIDERED UNCONFIRMED SINCE NO DEFECT WAS FOUND IN ANY OF THE VALVES.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED ON APRIL 10TH 2017: THE FEMALE PATIENT HAD AN UNDERLYING MEDICAL CONDITION OF NORMOINTENSIVE HYDROCEPHALUS. THE 2 VALVES DID NOT FUNCTION DURING THE SAME PROCEDURE. A THIRD PUDENZ VALVE WAS IMPLANTED AND FUNCTIONED CORRECTLY.

    Description of Event or Problem · 1

    ON MAR2017, IT WAS REPORTED THAT AFTER VENTRICLE PUNCTURE, CSF FLOWED NORMALLY. THE VENTRICULAR CATHETER WAS INSERTED AND CONNECTED TO THE VALVE AND PERITONEAL CATHETER. CSF DID NOT FLOW. VALVE WAS FLUSHED BY PRESSING THE RESERVOIR WITH NO CHANGES. THE PERITONEAL CATHETER WAS DETACHED AND THE VALVE WAS FLUSHED AGAIN BY PRESSING THE RESERVOIR. CSF DID NOT FLOW. THE VALVE WAS DETACHED AND CSF FLOWED SPONTANEOUSLY THROUGH THE VENTRICULAR CATHETER. THERE WAS NO PATIENT INJURY. THE EVENT DID NOT LEAD TO INCREASE IN SURGERY TIME. THE VALVE UNIT WAS EXPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED. LINKED TO MFG. REPORT NUMBER 2648988-2017-00007.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260424 PUDENZ VALVE, 16MM, BURR HOLE, MEDIUM PRESSURE N/A JXG INTEGRA NEUROSCIENCES PR 1154399

    Patients

    Seq Age Sex Outcome Treatment
    1