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 august 4, 2022.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 and device evaluation).H6 (identification of evaluation codes 10, 11, 3331, 4238, 25).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: 4238 - contamination of environment by device.Investigation conclusions: 25 - cause traced to manufacturing.The affected sample was inspected upon receipt to confirm a black mark in the reservoir.Further inspection revealed that the marking is embedded within the plastic.Using the final inspection and packaging in-process inspection criteria, the mark was measured and found to be out of specification measuring at 2.0mm².A representative retention sample was inspected to show no anomalies with the device, including no embedded foreign matter.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
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