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 30, 2019.Upon further investigation of the reported event, the following information is new and/or changed: d4 (additional device information - added exp date), g4 (date received by manufacturer), g7 (indication that this is a follow-up report), h2 (follow-up due to additional information), h6 (identification of evaluation codes (3331, 4114, 111, 57).Method code #1: 3331 - analysis of production records, method code #2: 4114 - device not returned, results code: 111 - packaging problem identified, conclusions code: 57 - cause traced to labeling.The sample was not returned, however, a picture was provided to confirm the complaint.The responsibility for removing the awaiting sterilization tags is with the distribution center.The director of site quality confirmed that the product was sterilized and the tags remaining on the boxes were in error.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
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