Additional information was added to h3, h6, and h10: h10: the device was received for evaluation.Visual inspection was performed and a separation between the female connector and main body was observed.Leak, clear passage, and clamp function testing were performed and no issues were observed.The reported condition was verified.The cause of the condition was determined to be manufacturing related due to an inadequate solvent bond between the female connector, insert chip, and main body.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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