The lot complaint history was reviewed; this is the seventh complaint for the finish goods lot and seventh for this issue for this lot.The device history record shows the product was released per specifications.No sample has been returned for evaluation; therefore, the condition of the product could not be verified.Custom-paks is an assemblage of single-use medical devices and accessories provided to the customer in a sterile manner.An evaluation is conducted to ensure each requested item meets customer, process, and regulatory requirements.Several sizes are available to accommodate the best fit for the custom-pak.Once the custom-paks are assembled and sealed, they are all sterilized as a complete unit.Sterilization has taken into account the worst case of the pouches to ensure all custom-paks meet all sterilization cycle parameters for acceptability prior to release.The root cause of the customer's complaint could not be established as a sample has not been received and the condition of the product could not be verified.Without analysis of the sample, it is not possible to isolate the root cause.As the root cause is unknown, the relationship, if any, of the device to the reported incident cannot be determined.After an investigation of this complaint, it has been determined that no action will be taken at this time as a sample was not returned and a root cause evaluation could not be performed.The manufacturer internal reference number is: (b)(4).
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