Additional information: h3, h4, h6, h10.H10: the actual device was received for evaluation.A visual inspection was performed, and it was noted that there was no evidence of fluid flowing out at the distal end of the flow restrictor.Microscopic inspection on the flow restrictor revealed the cause of flow problem was due to a series of micro-air bubbles blocking the fluid path inside the lumen of the capillary glass.The reported condition was verified.The cause of the condition was determined to be user related.Air bubbles inside the lumen of the capillary glass can be attributed to improper filling technique during product use (filling step).The product label (ifu, instructions for use) details the proper filling technique to avoid this type of occurrence.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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