H10: the device was received for evaluation.Visual inspection was performed, and a broken tubing line at the junction of the flow restrictor was observed.The reported condition was verified.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.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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