The customer did not retain the finished goods lot number, lot and order history could not be reviewed.The customer did not retain a sample for this complaint report; visual inspection or functional testing could not be conducted.The root cause of the customer's complaint could not be established as a sample has not been received.Without a sample, it is not possible to isolate the root cause.All products have been sterilized and all sterilization cycle parameters are verified for acceptability prior to release.As the root cause is unknown, the relationship, if any, of the device to the reported incident cannot be determined.After a thorough investigation of this complaint, it has been determined that no action will be taken at this time as a sample was not returned.Quality assurance will continue to monitor customer complaints and will take action for any future occurrences as is deemed necessary.The manufacturer internal reference number is: (b)(4).
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