The event involved a tego connector.The customer stated that the tego had, ¿degeneration of seal on bung, breakdown of outer plastic as well as the inner mechanism, unable to flush once broken.¿ there was blood loss of one whole circuit, roughly 200 mls.The patient¿s hemoglobin level was 101.The medical interventions required was the, ¿wash back of the machine, new machine was set up, loss of blood.¿ the tego was in use for less than 10 minutes.The setup was described as the tego was cleaned, lock off of line drew back through the bung, line was flushed, and then attached to hemodialysis machine.No other information was provided.This report is for the second of two events.
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One used list #d1000, tego connector (lot #4775688) was received and visually inspected.As received, the seal was torn in the area of the thread posts.The thread posts were also found to be bent and broken.No other damage or anomalies were observed.No mating devices were returned.The probable cause of the post damage observed is applying an unintentional excessive pulling force after the mating device threads are fully engaged with the d1000 tego during use.The fluid path of the tego sample was accessed using a 3 ml syringe from icu medical inventory that was modified to allow for fluid path visualization.The seal damage was such that when accessed with the syringe the seal collapsed onto itself thus occluding the fluid path.The reported complaint can be confirmed.The probable cause of the seal damage and subsequent occlusion of the fluid path is due to overtightening during use.Dfu states: when using a luer slip connection, only insert half-way while turning slightly clockwise.When removing, apply the same clockwise turning motion.Do not overtighten.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.
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