A device history record review was completed for provided material number 306575 and lot number 3130723.The review did not reveal any detected abnormalities during the production process that could have contributed to the reported defect and all quality tests were found to be within specification.Based on the investigation results, an exact cause could not be determined for the reported event.Per the provided feedback, we understand an issue with barrel label missing.All our prls (plunger rod assembly and labeler) have a vision system to detect issues in the barrel label, including missing label.In this case, the issue could probably be caused after the vision system due to a failure in the double rejection station.If the syringe has no label, the rejection station must reject it.However, if there is a failure in the rejection, the station stops and it does not allow to run the machine.Then, the operator must check which is the cause of the stoppage and remove the defective samples.This is a very unusual circumstance.Labelling is inspected on regular basis under quality assurance control sampling procedure.Based on our stringent sampling inspection, we are certain that the probability of occurrence of this non-conformance is low and this should correspond to an isolated case.However, an awareness bulletin for the reported defect has been communicated to the manufacturing affected area and a training has been conducted.Our quality team will continue to closely monitor the manufacturing process for signs of this potential defect and any emerging trends.
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