A device history review was conducted for lot number 8079074.Our records show the reported lot was manufactured in april of 2018, and determined that this is the third instance of this issue occurring in this production batch.According to the sampling plan applied for product performance, this lot was accepted and released without defects being noted during the final assembly or visual inspections.The facility's submitted samples and photographs for evaluation and testing.Measurements of the physical dimensions of the returned devices determined that they were out of specification for swage depth, making the cavity too narrow to hold the tubing adequately.Visual observation of the tubing determined that it had markings consistent with this, leading to leakage between the tubing and the adaptor.A review of the manufacturing process determined that the root cause is an obstruction of the swaging station¿s guiding camera during production.Although this is a rare occurrence, it is possible for the extension tubing to fall off the production line in a way that allows it to settle into a position that obstructs the guiding camera¿s eye, causing the swaging process to terminate prior to completion.The plant has optimized the camera system to prevent the recurrence of this event.Bd will continue to track and trend for this issue.
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