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

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

Event Date 07/28/2023

Event Type  Injury  

Event Description

On (b)(6) 2023, it was reported that this patient on peritoneal dialysis (pd) had peritonitis.There were no reported allegations of any issues with fresenius products in relation to the event.In an additional follow-up call, the patient¿s pd nurse stated that the patient was experiencing pd catheter (not a fresenius product) malfunction.On (b)(6) 2023, the patient was hospitalized and found to have peritonitis.Per the nurse, the patient had a pd culture obtained which generated growth of the bacteria staphylococcus (species not provided).The patient was treated with intra-peritoneal (ip) antibiotic therapy (details unknown).Additionally, the patient was switched to hemodialysis for renal replacement needs.On an unknown date, the patient was discharged from the hospital and continues hemodialysis on an outpatient basis.The patient continues antibiotic therapy with intravenous vancomycin (dose unknown).The nurse stated the patient is recovered from the peritonitis event.The nurse confirmed the patient did not have any fluid leaks or any issues with fresenius device or product in relation to the peritonitis event.The nurse attributed the peritonitis to a breach in aseptic technique during the pd exchange.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: PD CATHETER
• Type of Device: CATHETER, PERITONEAL, LONG-TERM INDWELLING
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17557532
• MDR Text Key: 321404197
• Report Number: MW5144601
• Device Sequence Number: 1
• Product Code: FJS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1
• Treatment: VANCOMYCIN.