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 a brand-new package was opened and the cap fell apart.Did not reach the patient.No packaging or lot available.No patient injury; never reached the patient.1 sample received (b)(6)2016.It was confirmed that there was 1 incident where the connector separated prior to use.No details surrounding the incident are available.Reported as product code 415303, lot unknown.This report is a post inspection retrospective review.2016 incident.
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