The complaint could not be confirmed.The iv set was received in condition making evaluation impossible.The iv set was within the opened pouch and the spike cap was on top of the spike.The cap did not fall off when the drip chamber was turned upside down.It is possible that the nurse put the cap back on after finding it was loose.Possible reason for the reported issue is that not enough pressure was applied to secure the cap.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 (b)(6) 2016.Zyno medical submitted an e-mdr (3006575795-2016-00120_complaint (b)(4)) on 10/26/2016 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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