Additional information was received for d9, h3, h6, and h11.H11: the actual sample was returned for evaluation.A visual inspection with the naked eye noted a separation between the female connector and the main body of the twist clamp.Functional tests were performed which included leak, clear passage, and clamp function tests with no issue observed.The transfer set was also connected and disconnected using an in-lab patient connector with no issues and no leaks observed.The reported condition of connection issue was not verified.However, the reported condition of separation was verified.The cause was determined to be a manufacturing related issue caused by 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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