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 march 17, 2022.Upon further investigation of the reported event, the following information is new and/or changed: h6 (identification of evaluation codes 3331, 4114, 3221, 4315).Type of investigation #1: 3331 - analysis of production records.Type of investigation #2: 4114 - device not returned.Investigation finding: 3221 - no findings available.Investigation conclusions: 4315 - cause not established.The actual sample was not returned so a detailed investigation could not be performed.Review of the manufacturing history record and the incoming inspection record of the actual sample confirmed that there were not any indications of anomaly in the them.A search of the complaint file found no other similar report with the involved product code/lot# combination.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
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