(b)(4).The device was manufactured july 10, 2014-july 11, 2014.The device was recieved for evaluation.Visual inspection revealed a solid white fragment of the duckbill valve component approximately 1.30mm in size, floating in the fluid of the reservoir.The particle was identified to be polyisoprene material via ft-ir spectrophotometer scanning, which is the material of the duckbill valve.The reported problem was verified.The cause of the problem could not be determined.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.A capa has been opened to address this issue.Should additional relevant information become available, a supplemental report will be submitted.
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