An unexpected return from the customer confirmed a female luer crack.Visual inspection confirmed that the female luer had a lateral crack.Closer inspection under a lab microscope observed no tool marks or signs of over torque.Functional testing confirmed a leak from the observed crack.No other leaks were observed throughout the set.The set was visually inspected for kinks, incomplete bonding engagements, holes/tears in the tubing or damages to the components.Visual inspection found a crack in the female luer wall on the opposite end of the injection gate of the set.The location of the luer gate on the female luer (below the ¿wings¿) indicates that this female luer was manufactured after the change order that moved the injection gate to a lower location to help mitigate and prevent female luer cracks.No tool marks or signs of over torque were observed.No damages were observed on the male luer.Functional testing resulted to a leakage from a cracked female luer.Device history record for model 10015817 could not be performed due to no lot number being provided by customer.The root cause of the crack is a result of internal stresses created in the luer during the manufacturing process that make it more susceptible to chemical/mechanical attacks.
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