Medical device expiration date: unknown.The customer's address is unknown.Device manufacture date: unknown.(b)(4).Investigation summary: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.The lot number is unknown, therefore device history record review (dhr) or quality notification review (qn) could not be performed.Investigation conclusion: unconfirmed: bd was not able to duplicate or confirm the customers indicated failure as no samples or photos were returned.Root cause description: no root cause can be determined as no samples were received.Rationale: complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.
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