Investigation: a device history review was conducted for lot number 8215502.Our records show that this is the only 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.Additionally, our engineers were able to duplicate this event through the leakage testing of the submitted device.A subsequent review of our manufacturing line determined that the most likely root cause for this event is an abnormality in the equipment responsible for tubing assembly.Bd was able to confirm the defect with the provided sample, for leakage issue in leakage/air in injection valve that have been detected in others customer complaints, the team previously confirmed issues with this product lot 8037509 where leakage occurred at the valve port assy.Due to a bad tubing assembly.Engineering team assessed the assembly process finding a worn pin in station 5 that could cause the reported failure mode.This pin is in charge of assembling the gray tubing into the valve housing.
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