NRFIT ADMINISTRATION SET

Additional Manufacturer Narrative

THIS FILE WAS ORIGINALLY INCORRECTLY FILED UNDER REGISTRATION NUMBER MRN 9617604-2025-00198. THE DATE OF THAT SUBMISSION WAS 19-MAR-2025. ONE DEVICE WAS RECEIVED FOR INVESTIGATION. THE REPORTED ISSUE WAS CONFIRMED DURING FUNCTIONAL TESTING WHEN THE REPORTED LEAKING ISSUE WAS DUPLICATED. HOWEVER, THE INVESTIGATION DID NOT IDENTIFY A ROOT CAUSE FOR THE OBSERVED CONDITION. THE PRODUCT'S HISTORY RECORDS WERE REVIEWED AND THERE WERE NO NON-CONFORMANCES NOR SERVICE-RELATED ISSUES THAT WOULD HAVE RESULTED IN THE REPORTED COMPLAINT. COMPLAINT INFORMATION WILL CONTINUE TO BE MONITORED.

Description of Event or Problem

IT WAS REPORTED THAT THE TUBING AT THE CLIP-ON LEAKED. THERE WAS PATIENT INVOLVEMENT, NO PATIENT INJURY WAS REPORTED.