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

Device Problem Contamination /Decontamination Problem (2895)

Patient Problems Bacterial Infection (1735); Peritonitis (2252)

Event Type  Injury  

Event Description

It was reported via a fresenius user facility survey that a peritoneal dialysis (pd) patient experienced peritonitis.In additional follow-up, the patient's pd nurse stated that on (b)(6) 2021, the patient had a pd culture obtained that yielded growth of staphylococcus aureus.It was reported the patient was treated with antibiotic therapy (unknown medication).However, the nurse stated the patient did not recover.Subsequently, on l (b)(6) 2021, the patient had another pd culture obtained which also grew the bacteria staphylococcus aureus.The patient reportedly continued antibiotics and underwent removal of the pd catheter (not a fresenius product).The nurse stated the patient has since been transitioned to hemodialysis and recovered from the peritonitis event.The patient's nurse confirmed the patient did not have any fluid leaks or any issues with a fresenius device or product in relation to the peritonitis event.The nurse attributed the peritonitis to touch contamination during the pd exchange.Moreover, it was indicated the peritonitis persisted due to bacteria in the pd catheter.(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: 17530538
• MDR Text Key: 321090397
• Report Number: MW5137457
• 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: 03/18/2022

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