inforMED
InjuryGBW

CATHETER, PERITONEAL

Received Aug 12, 2023

Report MW5136346 · MDR key 17529419

Device

Generic name

Catheter, Peritoneal

Manufacturer

Unknown

Product problems

  • Fluid/Blood Leak
  • Fluid/Blood Leak

Patient

Unknown

  • Peritonitis
  • Peritonitis

Narrative

Description of Event or Problem

THIS IS A SPONTANEOUS REPORT FROM A CONSUMER WITH SUPPLEMENTAL INFORMATION FROM A NURSE IN THE USA OF PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL THERAPY FOR PERITONEAL DIALYSIS. DURING A CALL WITH BAXTER CUSTOMER SERVICES, THE FOLLOWING WAS REPORTED. ON (B)(6) 2012, THE PATIENT EXPERIENCED PERITONITIS. ON (B)(6) 2013, THE PATIENT WAS HOSPITALIZED FOR THE EVENT. THE CAUSES OF PERITONITIS WERE URINARY TRACT PROBLEMS AND THE CATHETER SPRUNG A LEAK (ONSET DATES NOT REPORTED). ON AN UNREPORTED DATE, A PERITONEAL EFFLUENT CULTURE WAS PERFORMED AND THE RESULT WAS UNKNOWN. TREATMENT WAS NOT REPORTED. ON (B)(6) 2013, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. THE PATIENT WAS RECOVERING FROM THIS PERITONITIS EVENT. PATIENT INJURY REPORTED: YES. MEDICAL INTERVENTION REQUIRED: YES, (B)(4). THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).