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 october 22, 2021.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 11, 3331, 4114, 3259, 4315).Type of investigation: #1: 11 - testing of device from same lot/batch retained by manufacturer.Type of investigation #2: 3331 - analysis of production records.Type of investigation #3: 4114 - device not returned.Investigation findings: 3259 - improper physical structure.Investigation conclusions: 4315 - cause not established.The affected sample was not returned so a thorough investigation could not be conducted.Pictures provided with the complaint confirm the event.A representative retention sample was inspected with no visual anomalies, including no damage to the sampling manifold.All capiox units are 100% visually inspected at several points in the production process.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
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