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 may 31, 2022.Upon further investigation of the reported event, the following information is new and/or changed: g6 (indication that this is a follow-up report).H2 (follow-up due to additional information).H6 (identification of evaluation codes 3331, 4114, 4246, 4308).Type of investigation #1: 3331 - analysis of production records.Type of investigation #2: 4114 - device not returned.Investigation findings: 4246 - transport/storage problem identified.Investigation conclusions: 4308 - cause traced to transport/storage.The investigation verified that incorrect product was shipped.An sncr was sent for this incident to the appropriate distribution center for further investigation.The root cause was the distribution center picked and sent incorrect product.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
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