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 april 29, 2021.Upon further investigation of the reported event, the following information is new and/or changed: d4: (additional device information - added expiration date).G3: (date received by manufacturer).G6: (indication that this is a follow-up report).H2: (follow-up due to additional information).H4: (device manufacture date).H6: (identification of evaluation codes 11,3331, 4114, 3221, 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: 3221 - no findings available.Investigation conclusions: 4315 - cause not established.The complaint sample was not returned for investigation.Ops valves are subject to a 100% leak test, which includes five different tests the units are run through to ensure there are no leaks and both the umbrellas and duckbills are functioning properly.The retention sample was visually inspected with no anomalies noted on the device.The sample was then manually run through the ops leak tests to ensure each component of the device is functioning as normal.All ops valves are subjected to a 100% leak test that undergoes 5 separate programs to test that each component in the valve is functioning properly.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
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