ARROW RA CATH SET: 20 GA X 1-1/2 IN

Additional Manufacturer Narrative

(B)(4).

Description of Event or Problem

IT WAS REPORTED THAT ON (B)(6) 2026, "WHEN MEDICAL STAFF PERFORMED PREOPERATIVE INVASIVE ARTERIAL PUNCTURE ON THE PATIENT, THE RADIAL ARTERY WAS SUCCESSFULLY ACCESSED, YET NO BLOOD RETURN WAS OBSERVED. AFTER REMOVING THE ARTERIAL PUNCTURE CATHETER KIT, BLOCKAGE OF THE ARTERIAL PUNCTURE FLEXIBLE TUBING WAS CONFIRMED. FLUSHING WITH A NORMAL SALINE SYRINGE WAS INEFFECTIVE. THE MEDICAL TEAM HAD TO REPLACE THE ENTIRE ARTERIAL PUNCTURE CATHETER KIT AND PERFORM A SECOND PUNCTURE." THERE WERE NO REPORTS OF PATIENT INJURY, HARM, OR ADVERSE HEALTH CONSEQUENCES ASSOCIATED WITH THIS EVENT, ASIDE FROM PATIENT DISCOMFORT RELATED TO A SECOND PUNCTURE. THE PATIENT'S CONDITION WAS REPORTED AS FINE. NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED BEYOND REMOVAL OF THE AFFECTED DEVICE, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY FOLLOWING REPLACEMENT WITH A NEW DEVICE.