CATHETER, PERITONEAL

Description of Event or Problem

IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT WAS HOSPITALIZED FOR A POSSIBLE PD CATHETER (NOT A (B)(6) PRODUCT) INFECTION. THERE WERE NO REPORTED ALLEGATIONS OF ANY ADVERSE EVENTS ASSOCIATED WITH (B)(6) PRODUCTS. IN ADDITIONAL FOLLOW-UP, THE PATIENT¿S PD NURSE CLARIFIED THAT THE PATIENT WAS HOSPITALIZED ON (B)(6) 2026 FOR A PD CATHETER MALFUNCTION (NOT A PD CATHETER INFECTION) AS EVIDENCED BY THE PD CATHETER BEING UNABLE TO ASPIRATE OR DRAIN AFTER BEING FLUSHED IN THE PD CLINIC (EARLIER ON (B)(6) 2026). THE NURSE CONFIRMED THAT THE PATIENT DID NOT HAVE A PD RELATED INFECTION, DID NOT HAVE PERITONITIS, AND DID NOT HAVE ANY ADVERSE EFFECTS FROM (B)(6) PRODUCTS. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).