The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2021-11-16.H6: investigation summary seven syringes and photos received for investigation, upon visual inspection, no defects can be observed.The tip of the ten syringes of each lot do not present any visual defect.The lot number is unknown, therefore device history record review (dhr) or quality notification review (qn) could not be performed.Final products in this manufacturing line, for this reference are sampled and they are subjected to visual and functional inspections during the different manufacturing sub-processes according to procedures.Based on the quality team's investigation, we are not able to identify a root cause related to our manufacturing process at this time.
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