MAUDE Adverse Event Report: UNKNOWN CATHETER, PERITONEAL

Device Problem Break (1069)

Patient Problems Pain (1994); Peritonitis (2252)

Event Type  Injury  

Event Description

This is a spontaneous report by a consumer from canada of peritonitis in a 54-year-old male patient (age not reported) coincident with dianeal pd4 1.5% and 2.5% (dianeal_1.5% and 2.5% pd4_solution for peritoneal dialysis_bag, pvc) therapies.On an unreported date, a year ago, the patient began treatment with dianeal pd4 1.5% and 2.5% therapies (5l, 3 times per day, and lot numbers not reported) intraperitoneally (ip) for peritoneal dialysis (pd) for kidney not working well.On (b)(6) 2012, pd catheter was removed, pd therapy was discontinued and the patient started with hemodialysis therapy.During a call, the following was reported.On an unreported date, the patient experienced peritonitis manifested by pain in stomach.On (b)(6) 2012, the patient was hospitalized for peritonitis.Treatment was not reported.On (b)(6) 2012, the patient was discharged from the hospital.On (b)(6) 2012, the patient noticed that the pd catheter was broken and the patient was hospitalized again on 09dec2012 for the event.On (b)(6) 2012, the pd catheter was removed.On (b)(6) 2012, the patient was discharged from the hospital.It was reported that pd catheter broken might be the cause of peritonitis.On (b)(6) 2013 baxter product surveillance contacted local pharmacovigilance to obtain additional information on this event.Local pharmacovigilance was in the process of trying to obtain additional information from the facility.No further information was given at this time.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: 17531400
• MDR Text Key: 321137467
• Report Number: MW5138315
• 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: 01/22/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1