The returned valve was patent.Therefore the conditions of the complaint could not be duplicated by laboratory personnel.The instructions for use that accompany the device instruct that to perform the patency check ¿place the inlet connector of the valve into filtered, sterile isotonic saline.Depress and release the valve dome repeatedly until fluid flows from the outlet connector.To avoid retrograde flow, occlude the valve inlet when depressing the dome.If fluid flows from the outlet connector each time the dome is depressed, the valve is patent¿.The valve also met the requirements for siphon, reflux, preimplantation and leak testing.However, it did not meet the requirements for pressure flow testing.Proteinaceous debris was noted within the interior and exterior of the valve.The instructions for use that accompany the device caution that ¿shunt obstruction may occur in any of the components of the shunt system.The system may become occluded internally due to tissue fragments, blood clots, tumor cell aggregates, bacterial colonization or other debris¿.A review of the manufacturing records showed no anomalies.All valves are 100% tested at the time of manufacture.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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