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 june 15, 2022.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
|
This follow-up report is submitted to fda in accord with applicable regulations.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 and device evaluation).H3 (device evaluated by manufacturer).H4 (device manufacture date).H6 (identification of evaluation codes 10, 11, 3331, 213, 4315).Type of investigation #1: 10 - testing of actual/suspected device.Type of investigation #2: 11 - testing of device from same lot/batch retained by manufacturer.Type of investigation #3: 3331 - analysis of production records.Investigation finding: 213 - no device problem found.Investigation conclusions: 4315 - cause not established.The returned sample was inspected upon receipt, no anomalies were noted.Sample was tested for cr break through time, break through volume, and static volume.All results were within specifications.A representative retention sample from the same lot number was obtained, no visual anomalies noted.The retention sample was tested for cr break through time, break through volume, and static volume.All results were within specifications.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
|