CATHETER, PERITONEAL

Description of Event or Problem

THIS IS A SPONTANEOUS REPORT BY A CONSUMER FROM THE PHILIPPINES OF A LEAK IN THE EXIT SITE AND ACCIDENTAL REMOVAL OF THE CATHETER AND PERITONITIS IN A 45-YEAR-OLD FEMALE PATIENT COINCIDENT WITH DIANEAL PD2 1.5% AND 4.25% (DIANEAL PD2 WITH 1.5% AND 4.25% DEXTROSE) THERAPIES. ON (B)(6) 2012, THE PATIENT BEGAN TREATMENT WITH DIANEAL PD2 1.5% ( DOSE AND LOT NUMBER NOT REPORTED) AND DIANEAL PD2 4.25% (DOSE, FREQUENCY, AND LOT NUMBER NOT REPORTED) INTRAPERITONEALLY (IP) FOR CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD). ACTION TAKEN WITH DIANEAL THERAPIES WAS NOT REPORTED. DURING A CALL, THE FOLLOWING WAS REPORTED. ON AN UNREPORTED DATE, THE PATIENT HAD A LEAK IN THE EXIT SITE AND ACCIDENTALLY REMOVED THE CATHETER. ON (B)(6) 2013, THE PATIENT EXPERIENCED PERITONITIS MANIFESTED BY ABDOMINAL PAIN AND FEVER. PERITONEAL EFFLUENT ANALYSIS WAS NOT PERFORMED. THE CAUSE OF PERITONITIS WAS LEAK IN EXIT SITE AND ACCIDENTAL REMOVAL OF THE CATHETER. TREATMENT WAS NOT REPORTED. PATIENT INJURY REPORTED: YES (B)(4). THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).