BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-PURPOSE ON-OFF FLUSHING VALVE W ASD, MEDIU

    MDR report key: 6072341 · Received November 2, 2016

    Report

    Report Number
    2648988-2016-00048
    Event Type
    Malfunction
    Date Received
    November 2, 2016
    Date of Event
    October 11, 2016
    Report Date
    October 11, 2016
    Manufacturer
    INTEGRA NEUROSCIENCES PR
    Product Code
    JXG
    PMA / PMN Number
    K153041
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    DENTAL HYGIENIST

    Narratives

    Additional Manufacturer Narrative · 1

    INTEGRA HAS COMPLETED THEIR INTERNAL INVESTIGATION ON 01/23/2017. THE PRODUCT WAS NOT RETURNED FOR EVALUATION AND NO SAMPLE HAS BEEN RECEIVED FOR THIS COMPLAINT AT THE TIME OF THIS INVESTIGATION; THUS, COULD NOT BE CONFIRMED. REVIEW OF DEVICE HISTORY RECORD (DHR) DHR FOR THE FOLLOWING WERE REVIEWED: LOT 1150266 / NL850-0108 (MULTI-PURPOSE ON-OFF FLUSHING VALVE WITH ANTI-SIPHON DEVICE, MEDIUM). ALSO THE SUBASSEMBLIES RELATED TO THE ON-OFF FUNCTIONALITY WERE REVIEWED: LOT 1143046 / 100103-101 (BODY MPV ON-OFF); LOT 1143598 / 100102-101 (DOME MPV ON-OFF). ALL THESE TESTS PERFORMED BY THE MANUFACTURING DEPARTMENT MET THE ESTABLISHED REQUIREMENTS. UPON REVIEW OF INTEGRA'S COMPLAINT SYSTEM FROM OCTOBER 2014 TO OCTOBER 2016, THERE IS NO OTHER COMPLAINT RELATED TO THE REPORTED CONDITION FOR THE MULTIPURPOSE VALVES PRODUCT FAMILY. MULTI-PURPOSE VALVES ARE A LOW VOLUME PRODUCT. APPROXIMATELY (B)(4) UNITS WERE RELEASED FOR DISTRIBUTION FROM OCTOBER 2014 TO OCTOBER 2016. THIS COMPLAINT HAS NOT BEEN CONFIRMED AND IT IS MOST PROBABLE THAT THE EVENT IS RELATED TO A USER ERROR; THUS, THIS EVALUATION IS DONE FOR INFORMATION ONLY. IF CONFIRMED, THE COMPLAINT OCCURRENCE RATE FOR THIS TYPE OF INCIDENT WOULD BE (B)(4). CONCLUSION: IN THIS INVESTIGATION IT HAS BEEN DEMONSTRATED THAT: ALL VALVES WERE TESTED FOR PRESSURE AND ON-OFF CONTROL FUNCTIONALITY; THAT THE DEVICE, AS PER IFU INSTRUCTIONS, SHOULD BE SUBMITTED TO A PATENCY AND CLOSING PRESSURE TEST; THAT PRECAUTIONS MUST BE TAKEN IN ORDER NOT TO TEMPORARILY DEFORM THE SILICONE ELASTOMER MITER VALVE; THAT IF THESE TESTS ARE NOT PERFORMED, THERE ARE RISKS THAT THE RUBBER MAY STICK TO ITSELF DUE TO COMPONENTS BEING DRY; THAT INTEGRA RECOMMENDS THE USE OF A LOW PRESSURE SLIT VALVE OR DISTAL CATHETER WITH THE MULTI-PURPOSE VALVE IN ORDER TO ALLOW THE PROXIMAL MITER VALVE TO CONTROL SHUNT PRESSURE. INTEGRA MANUFACTURING PROCESS HAS ESTABLISHED PROCEDURES AND CONTROLS TO DETECT VALVE DEFECTS; THEREFORE, THE MOST PROBABLE CAUSE FOR THIS EVENT IS RELATED TO A USER ERROR. FAILURE TO FOLLOW IFU¿S RECOMMENDATIONS MAY HAVE PROVOKED THE REPORTED EVENT. SINCE THE VALVE HAS NOT BEEN RECEIVED THIS EVENT CANNOT BE CONFIRMED OR INVESTIGATED ANY FURTHER.

    Description of Event or Problem · 1

    ON (B)(6) 2016 THE NL8500108 MULTI-PURPOSE ON-OFF FLUSHING VALVE WITH ASD WAS IN USE ON A PATIENT WHEN THE SHUNT WAS NOT CLOSING. IT WAS UNKNOWN IF THERE WAS PATIENT INJURY OR DEATH ALLEGED, UNKNOWN IF A MEDICAL INTERVENTION OR REVISION WAS REQUIRED AND UNKNOWN IF THERE WAS ANY DELAY IN A PROCEDURE DUE TO THE PRODUCT PROBLEM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725558 MULTI-PURPOSE ON-OFF FLUSHING VALVE W ASD, MEDIU N/A JXG INTEGRA NEUROSCIENCES PR 1150266

    Patients

    Seq Age Sex Outcome Treatment
    1