Additional information was added to d9, h3, h4 and h6.H10: the device was received for evaluation.Visual inspection was performed using the naked eye which observed the tubing was blocked with a plastic piece completely plugging the pass of the fluid.Functional tests were performed including pressure test and clear passage which revealed a no flow due to a blockage in the tubing.The reported condition was verified.The cause of the condition was due to the occurrence of a material defect during the manufacturing of the tubing.A nonconformance has been opened to address this issue.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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