Date of event: unknown.Investigation summary: samples were received and an investigation was performed.This is the 8th complaint for the reported lot number.A review of the manufacturing records was performed and one non-conformance was raised in association with this type of event for this lot.Bd was able to duplicate or confirm the indicated issue and based on trend analysis no further action is required at this time.Complaints received for this device and reported condition will continue to be tracked and trended.Based on the above, no additional investigation and no corrective/preventative action (capa) or situational analysis (sa) is required at this time.
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