On (b)(6) 2016, the distributor reported to rymed that they had received notification that their customer had experienced an issue with the product.Reported that the nurse found a broken valve on the floor in the patient's room.The product had not been attached to a patient.The end cap was still attached to the set.No patient injury; never reached the patient.1 sample was received (b)(6) 2016.It was confirmed that there was 1 incident where the connector separated prior to use.No additional details surrounding the incident are available.Reported as product code 460207, lot unknown.This report is a post inspection retrospective review.2016 incident.
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