Terumo has not received the device for evaluation; therefore, the investigation has yet to be completed.Terumo plans on submitting a follow-up report when the investigation is complete and when more information becomes available.For this reason, terumo references evaluation conclusion code.(b)(4).
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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 nov 24, 2018.(b)(4).The sample was not returned for evaluation.A retention sample from the same product code and lot number was inspected and there was no damage anywhere on the device, specifically on the manifold line.All reservoirs are 100% visually inspected at several points in the production process.The packaging of the product also ensures protection against damage to any caps on the reservoir.It is likely that the cap was damaged by 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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