H.6.Investigation summary a device history record review was performed for provided lot number 9151991.The review did not reveal any detected quality issues during the production process and all inspections were found to be within specification.To further investigate this incident, two picture samples were provided for evaluation by our quality engineer team.Through examination of the pictures, it appears that the leakage was coming from the persist package.Through examination of the picture, further damage could not identified and therefore, the complaint of broken product could not be substantiated.During the manufacturing process, the bd persist single package is inspected for signs of damage.At this time, a manufacturing related cause for this issue cannot be determined.A notification has been send to the suppliers affiliated with this product to further investigate this incident.
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