(b)(4).Two used filtered extension sets, without packaging, were received for evaluation.Both sets were received attached to a microbore tubing set.In an attempt to replicate the reported event, the returned sample set-ups (with microbore tubing set still attached) were spiked and primed according to the instructions for use (ifu).There were no air bubbles observed within the filtered extension set tubing line or the microbore tubing set.Furthermore, the sets were subjected to occlusion and air pressure (leakage) testing according to specification with acceptable results.Review of the discrepancy management system database performed for the reported lot number did not reveal any abnormalities or nonconformances of this nature.No adverse quality trends of this nature were identified during the complaint review process for the reported catalog number or lot number.Based on the results of this investigation, no specific conclusions can be made regarding the cause of the reported event.The returned samples met requirements according to specification, and the reported failure could not be reproduced.If additional pertinent information becomes available, a follow-up report will be filed.
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