(b)(4).One empty 1650 ml water reservoir lot: 19a145 was received for evaluation.The water bottle arrived with both ports punctured: the top port was punctured cleanly without port inversion; the bottom port was inverted such that the port did not rupture cleanly.Complaint "incomplete puncture" confirmed as reported.In review of device history record, manufacturing event log shows no issues that may have contributed to any quality issues reported.All process parameters were within specification, and all qa inspections were acceptable.A sample of the spike used on the sample's bottom port is needed for further investigation.Port inversion can occur due to a dull spike.Port inversion can also be due to improper spike technique by a user (per instructions for use, connect the tube to the port "by piercing the port with spike using a twisting motion").Root cause unknown.A non-conformance was opened to further address this issue.
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