Investigation summary: the batch record, quality notification and maintenance records were analyzed for catalog 990628, lot number 3147192, and no deviation was found.Without samples or photos it was not possible to determine the root cause.Complaint was not confirmed.Based on no sample/no photo, the investigation concluded: unconfirmed: bd was not able to confirm the customer¿s indicated failure.00 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 investigation conclusion: the batch record, quality notification and maintenance record were verified and no deviation was found.Without samples or photos it was not possible determine the root cause.Complaint not confirmed.Root cause description: without samples or photos it was not possible determine the root cause.
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