(b)(4).Upon completion of the investigation it was noted that the images were taken of the ¿as received¿ valve.The position of the cam when valve was received was 150 mmh2o.The valve was visually inspected: some biological debris was noted inside the valve as well as needle holes in the needle chamber.The valve was hydrated.The valve was tested for programming with programmer 82-3126 with serial (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.Leaked from the needle holes in the needle chamber.The valve was reflux tested.The valve passed the test.The siphon guard was tested.The siphon guard passed the test.The valve was dried.The siphon guard was removed.Review of the history device records for the valve, product code ns9008, with lot cvfcvm showed an nr report when released to stock on the 17th june 2016, the nr report issue had no link to this complaint.No root cause could be determined; as no problem was noted with the valve.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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