This follow-up report is submitted to fda in accord with applicable regulations ¿ and as indicated by terumo cardiovascular systems in the initial report submitted to the fda on june 6, 2017.Upon further investigation of the reported event, the following information is new and/or changed: (b)(4).No sample was returned for evaluation.Upon review of the tracking information, it was confirmed that 9 cases had been missing from the shipment.The cause of the missing cases was that the second page of the pick slip had been detached and misplaced by the associates at the (b)(4) distribution center.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
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