NRFIT EXTENSION SET W/ FILTER

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.

Additional Manufacturer Narrative

H3. REASON DEVICE NOT EVALUATED BY MFG: OTHER; DEVICE WAS NOT RETURNED TO MANUFACTURER. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.

Additional Manufacturer Narrative

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.