(b)(4).One empty 381-50, 1650 ml, reservoir lot 20a092 was received for evaluation."2a" was embossed in the plastic of the bottom of the reservoir.The reservoir arrived with both ports punctured.The bottom port had been punctured cleanly without port inversion.The top port on the reservoir was inverted such that the port had not ruptured cleanly.No other visual defects were observed.In review of the reservoir lot's device history record: manufacturing event logs showed no issues that may have contributed to the quality issue reported; process parameters were within specification; and qa inspections were acceptable, including port penetration tests.A sample of the puncture pin used on the sample's top port is needed for further investigation.Port inversion can occur due to a dull puncture pin.Port inversion can also be due to improper spike technique by a user (per product label, "push and twist the puncture pins through the puncture sites").Complaint "couldn't puncture the top water port" may be due to the user pushing the spike into the port without twisting.No column sample is available from the customer, so complaint inability to pierce reservoir bottle cannot be suitably investigated.Root cause is unknown.
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