ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 20 CM

Additional Manufacturer Narrative

(B)(4).

Description of Event or Problem

IT WAS REPORTED THAT ON (B)(6) 2026, DURING THE INITIAL INSERTION OF AN ACUTE HEMODIALYSIS CATHETER (AHDC), THE CATHETER BECAME KINKED. ATTEMPTS WERE MADE TO MANIPULATE AND REPOSITION THE CATHETER; HOWEVER, BLOOD RETURN WAS OBSERVED FROM ONLY ONE LUMEN, WHILE THE OTHER LUMEN EXHIBITED NO BLOOD RETURN. MULTIPLE ADJUSTMENT ATTEMPTS WERE UNSUCCESSFUL IN RESOLVING THE ISSUE. THE CATHETER WAS SUBSEQUENTLY REMOVED AND REPLACED WITH A NEW DEVICE, WHICH WAS SUCCESSFULLY INSERTED AND FUNCTIONED AS INTENDED. THERE WERE NO REPORTS OF PATIENT INJURY, HARM, OR ADVERSE HEALTH CONSEQUENCES ASSOCIATED WITH THIS EVENT. THE PATIENT'S CONDITION WAS REPORTED AS "FINE," AND NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED.