NRFIT EXTENSION SET W/ FILTER

Additional Manufacturer Narrative

THIS FILE WAS ORIGINALLY INCORRECTLY FILED UNDER REGISTRATION NUMBER MRN 9617604-2025-00118. THE DATE OF THAT SUBMISSION WAS 2/10/2025. DEVICE EVALUATION: ONE DEVICE WAS RECEIVED FOR DEVICE ANALYSIS. FUNCTIONAL TESTING AND VISUAL INSPECTION WAS PERFORMED. VISUAL INSPECTION FOUND NO DAMAGE OR ANOMALIES. FUNCTIONAL TESTING COULD CONFIRM THE REPORTED CUSTOMER COMPLAINT. A LEAK WAS OBSERVED FROM THE FILTER OUTLET TUBE. THE ROOT CAUSE IS DUE TO INCOMPLETE SOLVENT APPLICATION ERROR.

Description of Event or Problem

IT WAS REPORTED THAT A LIQUID LEAK OCCURRED DURING PRIMING. THIS OCCURRED BEFORE PATIENT USE/DURING PRIMING AT FACILITY. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.