ARROW HEMODIALYSIS KIT: 2-L 15 FR X 19 CM

Additional Manufacturer Narrative

(B)(4).

Description of Event or Problem

IT WAS REPORTED THAT ON (B)(6) 2026, DURING USE OF A CANNON II PLUS RETROGRADE CHRONIC HEMODIALYSIS CATHETER (CHDC), IT WAS OBSERVED THAT THERE WERE CRACKS AND BLOOD OOZING FROM THE CONNECTOR. THE CATHETER HAD ORIGINALLY BEEN INSERTED ON (B)(6) 2026. THE AFFECTED DEVICE WAS REMOVED AND REPLACED WITH ANOTHER DEVICE, WHICH FUNCTIONED AS EXPECTED. THERE WERE NO REPORTS OF PATIENT INJURY, HARM, OR ADVERSE HEALTH CONSEQUENCES ASSOCIATED WITH THIS EVENT. THE PATIENT'S CONDITION WAS REPORTED AS "FINE." NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED.