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 when the device was removed from the package, the cap fell apart.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 details surrounding the incident are available.Reported as product code 415303, lot m00137.This report is a post inspection retrospective review.2016 incident.
|