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.Upon further investigation of the reported event, the following information is new and/or changed: (identification of evaluation codes 4114, 11, 3331, 3259, 4307).Method code #1: 4114 device not returned.Method code #2: 11 testing of device from same lot/batch retained by manufacturer.Method code #3: 3331 analysis of production records.Results code: 3259 improper physical structure.Conclusions code: 4307 cause traced to component failure.The sample was not returned for evaluation, however, a picture was received and reviewed, confirming the blue cap had fallen off of the reservoir outlet.A retention sample from the same product code and lot number combination was inspected and found to still have the blue cap attached.The most likely root cause of the blue cap falling off is due to handling, post shipping, after the tcvs manufacturing process.All reservoirs are 100% visually inspected at several points in the production process.It is likely that the cap fell off due to a shock force at some point during the handling of the product; however, when or how this shock force was applied was not able to be determined.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
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