On (b)(6) 2022, zyno medical received a complaint from an end user regarding a leaking issue.It was reported that "the leak was coming from below the bottom filter on the tubing, and it would happen immediately." the end user also stated that "this event took place 4 times in a single day all on (b)(6) 2022".The device operator was a nurse.Medication being infused was remicade.There was a patient involved.The patient was not harmed or injured.The contract manufacturer of the affected device is (b)(4).
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