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 20, 2017.(b)(4).The sample was not returned for evaluation.Five retention samples from the same product code/lot number combination were visually inspected and confirmed to have all of the necessary holes punched out of the outer perimeter of the device.A review of the device history record revealed no manufacturing anomalies.The complaint was not confirmed and a definitive root cause was not able to be determined.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
|