Investigation summary: one physical sample and one picture sample were received for evaluation by our quality engineer team.Upon visual inspection of the samples, the stopper was observed to be incorrectly assembled and partially detached from the plunger.A device history record review did not reveal any documented issues during the production of the provided lot number that could have contributed to the observed/reported defect.The observed defect has been caused by a misalignment during the assembly process.There is a photo-cell in the assembly station to detect improper stopper assembly, however, this incident went undetected.The reason for the lack of detection and the misalignment could not be determined.Investigation conclusion: although no issues were identified and manufacturing record established that all production and quality processes were carried out normally, we can confirm that the root cause of the non-conformance is related with a misalignment of plunger-stopper-barrel in the assembly station.
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