MAUDE Adverse Event Report: UNKNOWN CATHETER, PERITONEAL

Device Problem Fluid/Blood Leak (1250)

Patient Problems Abdominal Pain (1685); Peritonitis (2252)

Event Type  Injury  

Event Description

This report was received from global pharmacovigilance (gpv) and is a spontaneous report by a nurse with supplemental information from the local complaint coordinator from the philippines of leak and peritonitis in a patient coincident with dianeal therapies for continuous ambulatory peritoneal dialysis (capd).On (b)(6) 2012, the patient experienced and was hospitalized for peritonitis manifested by abdominal pain and cloudy effluent.The cause of peritonitis was leak (entry site/surgery site/wound).The nurse stated that the leaking around the peritoneal catheter exit site was the cause of the peritonitis.The nurse stated that the patient did not have an exit site or tunnel infection.It was reported that the surgery was for insertion of the peritoneal catheter.The reported leak was leaking peritoneal effluent from the entry site of the peritoneal catheter.The nurse reported that the leaking fluid was due to the patient having weak muscles that could not hold the catheter well.The nurse reported that there had been no overfill events on the cycler that would have caused the leak.On (b)(6) 2012, the peritoneal effluent was analyzed before starting the antibiotic medication and the results revealed a leukocyte count of 3380 cells/mm3, 96% neutrophils, and 04% monocytes.The patient was treated with ciprofloxacin (500mg orally, twice daily) and vancomycin (500mg, 3 times for every 5 days, intravenously) for peritonitis.At the time of this report, the patient had not recovered from this peritonitis event.On an unreported date, dianeal therapies were withdrawn and the patient was on hemodialysis until the exit site completely healed.Patient injury reported: yes.Medical intervention required: yes (b)(4).This report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).

• Brand Name: CATHETER, PERITONEAL
• Type of Device: CATHETER, PERITONEAL
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17525080
• MDR Text Key: 321145815
• Report Number: MW5132022
• Device Sequence Number: 1
• Product Code: GBW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/25/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1