H10: the device was received for evaluation.A visual inspection was done which observed contamination-pm (particulate matter) outside the fluid path, between the walls of the tubing.A laboratory analysis was performed which revealed the particulate as, black embedded degraded pieces of burned plastic resin in the tubing.The reported condition of pm was verified.The cause of the condition was due to a manufacturing issue during the extrusion process.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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