Updated udi: (b)(4).Device evaluation: model #/lot #, device available for evaluation?, date received by mfr, type of reports, if follow-up, what type?, device evaluated by mfr?, device manufacture date, evaluation codes, additional mfr narrative.Upon completion of the investigation it was noted that the images were taken of the ¿as received¿ valve.The valve was visually inspected: needle holes in the needle chamber were noted, and a slight bend in the proximal connector.The position of the cam when valve was received was 170 mm h2o.The valve was hydrated for 24 hours.The valve was tested for programming with programmer 82-3126 with serial number (b)(4), the valve passed the test.The valve was flushed, the valve passed the test no occlusion was noted.The valve was leak tested, only leaked from the needle holes in the needle chamber.The catheters were irrigated, no occlusions were noted.The valve was reflux tested, the valve passed the test.The valve was dried.The valve was then pressure tested, the valve passed the test.Review of the history device records confirmed the valve product code 82-3148, with lot cvgbyt, conformed to the specifications when released to stock on the 29th june 2016.No root cause could be determined, as the problem reported by the customer could not be duplicated.Based on the results of this investigation no further action is required.Trends will be monitored for this and similar complaints.At the present time this complaint is closed.
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