Additional information was added to d9, h3, h6 and h10.H10: the device was received for evaluation.A visual inspection with the naked eye noted a separation between the female connector and main body.Functional testing including leak, clear passage, and clamp function testing were performed with no issues noted.The reported condition was verified.The cause of the condition was related to inadequate solvent application to the main body during the manufacturing process.A batch review was conducted and there were no deviations found related to this condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.
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