H4: the lot was manufactured between july 18, 2023 - july 20, 2023.H10: the actual device was received for evaluation.Visual inspection was performed which noted fluid inside a bag that contained the unit.Further inspection identified a broken tubing at the solvent-bonded junction of the flow restrictor.Remnant of broken tubing remained inside the solvent-bonded area of the flow restrictor.The morphology of the end of the broken tubing and internal sites of breakage suggested there was extra solvent present which caused melting of the tubing.The melting likely decreased the integrity of the tubing, causing breakage to occur.The reported condition was verified.The cause of the breakage was determined to be related to solvent application during manufacturing.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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