The customer did not retain the product lot information.Therefore, the device history records traceable to the reported procedure pack could not be reviewed.A sample was not returned.And no lot information is available.Therefore, the root cause for the customer reported event cannot be determined.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.All procedure paks are single-use devices provided to the customer in a sterile manner.In-process controls are established to ensure each final assembled cassette is verified, that all required tests have been performed and all acceptance criteria are met prior to release.Quality assurance has reviewed this complaint.And will continue to monitor data for evidence of adverse trending and take further action as appropriate.Consumables manufacturing management has been made aware of this complaint through the consumer affairs review meeting.The manufacturer internal reference number is: (b)(4).
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