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 15, 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 findings: 3221 - no findings available.Investigation conclusions: 4315 - cause not established.The affected sample was not returned; therefore, detailed analysis could not be performed.Based on the results of the investigation, no anomaly was found in the manufacturing related records.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
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