A) the iv set was not returned to the manufacturer for evaluation.B) the complaint was determined as not mdr reportable at the initial determination by following company procedures.This mdr is retrospectively filed as a corrective action to address one of the fda inspection observations made on 08/11/2016.C) zyno medical submitted an e-mdr (3006575795-2016-00145_complaint (b)(4)) on 10/27/2016 through the fda's website and received the receipt.But due to some technical difficulties and confusion, the file didn't pass with all three acknowledgements.This is a re-submission regarding the same event.
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