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

Catalog Number PD CATHETER

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

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 02/14/2021

Event Type  Injury  

Event Description

A patient's peritoneal dialysis registered nurse (pdrn) reported the patient went to the emergency room on (b)(6) 2021.The patient experienced adverse effects of issues with their pd catheter (not a fresenius product).The issues required medical intervention including being admitted to the hospital.The patient had the pd catheter pulled during the hospitalization and their dialysis modality was transitioned to hemodialysis (hd).The patient was expected to be discharged and begin in-center hemodialysis on (b)(6) 2021.The hospitalization was unrelated to the use of the liberty select cycler or other fresenius product(s).The patient hospitalization was a result of the pd catheter issue.There is no indication of a serious injury, patient death, or other adverse event related to a fresenius product or other issue warranting further investigation.C- 73945.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: 17527986
• MDR Text Key: 321139461
• Report Number: MW5134917
• 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: 03/08/2021

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
• Device Catalogue Number: PD CATHETER
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1