Additional information was added to d10, h3, h4, and h6.H10: two (2) devices were received for evaluation.A visual inspection was performed, and it was noted that except for the tip protectors, all the components were present and assemble according to specification.It was also noted that there were holes in the tubing of both returned devices resembling holes made by a needle.It was also observed that the connectors had a rubber footprint and were sticky as if they had been glued with cloth tape.Functional leak testing was performed, and it was noted that there were leaks from the holes in the tubing.The reported condition was verified.The cause of the reported condition 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.Should additional relevant information become available, a supplemental report will be submitted.
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