Investigation: three injector samples, three connector samples, and three protector samples were received for evaluation by our quality engineer team.A device history record review was performed for the protector lot number, 1806121, and the review did not reveal any quality issues during the production process that could have contributed to this incident.Through visual inspection of the samples, no defects were observed.Leakage testing was performed for each sample and no signs of leakage were observed.The injectors and connectors were attached to an infusion bag and no signs of leakage were observed.The protectors were connected to vials they performed per specification with no signs of leakage.As no signs of leakage, including vapor leakage, were observed, a cause for the reported incident could not be determined.
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