Terumo has not received the actual 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 more information becomes available.For this reason, terumo referenced evaluation conclusion code 11.(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 november 18, 2016.(b)(4).A sample was not returned for evaluation.Available retention samples from some of the same product code/lot number combinations delivered to australia were inspected.The products were removed from the packaging and their breather bags, and no caps were found to fall off or to be loose on their ports.A definitive root cause could not be determined; therefore, this complaint is not confirmed.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
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