MAUDE Adverse Event Report: UNKNOWN CATHETER, PERITONEAL

Device Problem Fluid/Blood Leak (1250)

Patient Problem Peritonitis (2252)

Event Type  Injury  

Event Description

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).

• Brand Name: CATHETER, PERITONEAL
• Type of Device: CATHETER, PERITONEAL
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17529419
• MDR Text Key: 321131706
• Report Number: MW5136346
• 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: 03/15/2013

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