MAUDE Adverse Event Report: UNKNOWN PERITONEAL DIALYSIS CATHETER; CATHETER, PERITONEAL, LONG-TERM INDWELLING

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Peritonitis (2252); Fungal Infection (2419)

Event Type  Injury  

Event Description

On 23 nov 2011, (b)(4) received a report by a consumer of peritonitis with culture positive for fungal in a patient coincident with dianeal pd4 ambuflex therapy for peritoneal dialysis (pd).During a call with baxter customer service, the following information was reported.On (b)(6) 2011, the patient experienced peritonitis.On (b)(6) 2011, the patient was hospitalized.On an unreported date, in (b)(6) 2011, a peritoneal effluent culture was done with results positive for fungal.The consumer reported that the peritonitis was caused from catheter.Treatment was not reported.At the time of this report, the patient was recovering.On an unreported date, dianeal therapy was withdrawn.On 24 july 2012, product surveillance spoke with the registered nurse (rn) regarding the home patient's (hp) catheter.The rn stated that he did not have any information regarding the catheter.Patient injury reported: yes medical intervention required: unknown.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: PERITONEAL DIALYSIS CATHETER
• Type of Device: CATHETER, PERITONEAL, LONG-TERM INDWELLING
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17534746
• MDR Text Key: 321152199
• Report Number: MW5141646
• Device Sequence Number: 1
• Product Code: FJS
• 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: 08/03/2012

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