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 june 12, 2020.Upon further investigation of the reported event, the following information is new and/or changed: h6 (identification of evaluation codes 11, 3331, 4114, 3259, 4308).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: 3259 - improper physical structure, conclusions code: 4308 - cause traced to transport/storage.The affected sample was not returned for investigation, however, pictures were provided confirming box damage to the one piece box.The box appears to have had force applied crushing the front and doing damage to the internal packaging material.Retention samples of the same lot were inspected and found to have no packaging damage.Upon evaluation of the sample pictures, it was confirmed that the unit box had been damaged.All capiox units are 100% visually inspected during and after packaging.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
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