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 may 15, 2020.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).H4 (device manufacture date).H6 (identification of evaluation codes 11, 3331, 4114, 111, 57).Method code #1: 11 - testing of device from same lot/batch retained by manufacturer.Method code #2: 3331 - analysis of production records.Method code #3: 4114 - device not returned.Results code: 111 - packaging problem identified.Conclusions code: 57 - cause traced to labeling.The actual sample was not returned for investigation; however, photos provided confirmed the missing box label.A retention sample was inspected and was found to be labeled properly.Review of device history records were reviewed indicating no abnormalities related to this issue.Capiox labeling is 100% inspected and label reconciliation is completed ensure each part meets tcvs specifications.All available information has been placed on file in quality management for appropriate tracking, trending and follow-up.
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