PD CATHETER

Description of Event or Problem

A PERITONEAL DIALYSIS (PD) PATIENT CONTACT REPORTED TO (B)(6) THAT THE PATIENT'S CATHETER WAS REPLACED AND WORKING VERY WELL UNTIL THEY STARTED PASSING BLOOD (IT WAS NOT SPECIFIED IF THE ISSUE OCCURRED DURING TREATMENT). THE PATIENT WENT TO THE EMERGENCY ROOM (ER) FOR THIS ISSUE AND WAS ADMITTED. THE PATIENT CONTACT MENTIONED THE NURSE TOLD THEM IT WAS DUE TO SCAR TISSUE AND THE CATHETER BEING LOOSE. IN ADDITIONAL FOLLOW-UP, THE PATIENT¿S PD NURSE CONFIRMED THAT THE PATIENT DID NOT HAVE ANY ADVERSE EFFECTS FROM (B)(6) PRODUCTS. THE NURSE INDICATED THAT THE PD CATHETER WAS REPLACED DUE TO PD CATHETER MALFUNCTION AND THAT THE BLEEDING WAS DUE TO POST-SURGICAL SCAR TISSUE. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).