The customer did not retain the product lot information for this custom pak, therefore the device history records traceable to the reported procedure pack could not be reviewed.No sample has been returned for evaluation; therefore, the condition of the product could not be verified.No lot number was identified with this complaint; therefore, lot history and complaint history reviews could not be conducted.A custom-pak 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 pak and item in the pak meets customer, process, and regulatory requirements.Several sizes are available to accommodate the best fit for the custom-pak.Once the custom-pak is assembled and sealed, they are all sterilized as a complete unit.The sterilization validation 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 therefore the condition of the product could not be verified.As the root cause is unknown, the relationship, if any, of the device to the reported incident cannot be determined.The root cause for this complaint is not known, therefore, specific action with regards to this complaint cannot be taken.Custom pak and the components inside of the paks are single-use items provided to the customer in a sterile manner.Quality assurance has reviewed this complaint and will continue to monitor data for evidence of adverse trending and take further action, as appropriate.No additional action is required at this time.The manufacturer internal reference number is: (b)(4).
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