PORTEX NRFIT EPIDURAL CUSTOM KIT

Additional Manufacturer Narrative

H3: DEVICE NOT RECEIVED BY MANUFACTURER. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. INVESTIGATION IS STILL IN PROGRESS.

Description of Event or Problem

IT WAS STATED THAT NRFIT SCIATIC AND FEMORAL NERVE CATHETERS WERE INSERTED SEPARATELY ON (B)(6) 2025. BOTH WERE CONNECTED TO SEPARATE 5 ML PER HOUR PUMPS. THE FEMORAL NERVE CATHETER WAS COMPLETELY DRAINED BY(B)(6) 2025, BUT THE SCIATIC NERVE CATHETER WAS ABOUT HALF DRAINED. MANUAL BOLUS ADMINISTRATION OF THE FEMORAL CATHETER VIA THE EXISTING FILTER AND CONNECTOR WAS NORMAL. EXTREMELY HIGH PRESSURE WAS ENCOUNTERED WHEN ATTEMPTING TO BOLUS THE SCIATIC NERVE CATHETER. NEW FILTER INSTALLED AND CONNECTED, FLUSHED WITHOUT PROBLEM, BUT AFTER CONNECTING IT TO THE CATHETER, THE SAME PROBLEM OCCURRED: VERY HIGH PRESSURE AND NOT FLUSHING. ANOTHER ATTEMPT WITH A NEW CONNECTOR-FILTER FROM AN EPIDURAL PACK WITH THE SAME PROBLEM. THE PATIENT'S CATHETER APPEARED TO BE UNDAMAGED AND PATENT UPON VISUAL INSPECTION. WHEN THE NEW FILTER-CONNECTOR COMBINATIONS WERE THEN INITIALLY TESTED ON THE NEW EPIDURAL CATHETER, THEY FLUSHED THE CATHETER WITHOUT PROBLEM. HOWEVER, WHEN UNLOCKING AND LOCKING THE CONNECTOR, THEY COULD NO LONGER FLUSH DESPITE NO OBVIOUS DAMAGE BEING VISIBLE. THERE WAS PATIENT INVOLVEMENT. THE INCIDENT HAS BEEN REPORTED TO THE REGULATORY AGENCY. NCA REFERENCE 2025 003 009 501 016 AND MHRA REFERENCE 34982960-AICXML. ASSOCIATED CATHETER AND MINIPACK COMPLAINTS DOCUMENTED ON (B)(6).

Additional Manufacturer Narrative

THIS COMPLAINT WAS INCORRECTLY FILED UNDER THIS REGISTRATION NUMBER, PLEASE REFERENCE MRN 3012307300-2026-00436-00 FOR DETAILS PERTINENT TO THIS EVENT.