Received one 18ga nexiva unit within an open package from lot number 7286659.The needle-shield assembly was partially disengaged.A complaint history check was performed and this is the 1st related complaint reported with the defect/condition of tubing damaged-defective-other with lot #7286659 regarding item #383519.Dhr review shows a total of (b)(4) units were manufactured on nexiva line 1 starting on oct 16, 2017 through oct 20, 2017.2 non-related qns (retraction failure) 200713406 and 200713575 were initiated during the production of the lot number associated with this incident.Disposition of the product, root cause and corrective action were applied according to the quality control plan.All other challenge, set-up and in process samples including (but not limited to) correct assembly and part air-water-leak test passed per specification.Visual evaluation of the unit revealed the end of the extension tube was not correctly inserted into the winged adapter port (kinked) and had left a partial gap of tubing out.This condition would cause leakage as experienced by the customer.This defect occurs during the manufacturing process on zone 8 at the adhesive dispense station if the catheter adapter is misaligned during the insertion of the extension tube.Current process controls include routine leak testing after zone 9 as well as a 100% online flow tester in zone 8.Customer complaint trends are evaluated on a monthly basis.If the trend of a specific type of complaint warrants a formal corrective action, resources will be assigned at that time.
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