CATHETER, PERITONEAL

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT EXPERIENCED PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. ON (B)(6) 2013, THE PATIENT EXPERIENCED PERITONITIS AND WAS HOSPITALIZED ON THE SAME DAY FOR PERITONITIS. THE CAUSE OF PERITONITIS WAS A CRACKED CATHETER. ON (B)(6) 2013, THE PATIENT DISCONTINUED PD THERAPY AND WAS STARTED ON HEMODIALYSIS. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2013. THE NURSE STATED THAT SHE DOES NOT HAVE THE INFORMATION ABOUT THE CATHETER, INCLUDING THE MANUFACTURER. NO FURTHER INFORMATION WAS PROVIDED. PATIENT INJURY REPORTED: YES. MEDICAL INTERVENTION REQUIRED: YES CMPLNT. (B)(4). THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).