(b)(4).Device manufacture date: february 19, 2016 ¿ february 20, 2016.The device was received for evaluation.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.A visual inspection was performed and revealed a surface cut located on a segment of the tubing.The surface cut was measured to be approximately 2.11 mm in length.There was no leak observed despite the surface cut on the tubing.The reported condition was verified.The cause of the condition could not be determined.Should additional relevant information become available, a supplemental report will be submitted.
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