On (b)(6) 2022, the distributor reported to rymed that they had received notification that their customer had experienced an issue with the product.Reported that the rymed product fell apart.The product had not been used on a patient.The end cap was still attached to the set.No patient injury; never reached the patient.Sample was received (b)(6) 2022.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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