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 july 10,2020.Upon further investigation of the reported event, the following information is new and/or changed: h3 (device evaluation anticipated by manufacturer - a second follow-up will be submitted upon completion of the investigation and/or submission of new information, thus tcvs references conclusions code 11.) 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: h6 (identification of evaluation codes 10, 11, 3331, 170, 25).Method code #1: 10 - testing of actual/suspected device, method code #2: 11 - testing of device from same lot/batch retained by manufacturer, method code #3: 3331 - analysis of production records, results code:170 - manufacturing process problem identified, conclusions code: 25 - cause traced to manufacturing.The affected sample was inspected and confirmed that a plastic piece of foreign matter was found contained inside the filter.The photo provided shows a white and brown piece of foreign matter in a port.A representative retention sample was reviewed with no issues noted including fm.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
|