MAUDE Adverse Event Report: PD (PERITONEAL DIALYSIS) CATHETER; CATHETER, PERITONEAL, LONG-TERM INDWELLING

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

Patient Problems Unspecified Infection (1930); Peritonitis (2252)

Event Date 06/23/2023

Event Type  Injury  

Event Description

On (b)(6) 2023 this female peritoneal dialysis (pd) patient¿s spouse reported the patient had an infection due to pd.It was reported the patient was diagnosed with peritonitis.Follow-up with the peritoneal dialysis registered nurse (pdrn) confirmed the patient was admitted to the hospital on (b)(6) 2023.A note in the patient¿s record indicated there was a pd catheter (not a fresenius product) infection.The patient had the catheter removed and transitioned to hemodialysis (hd).The pdrn could not confirm if the infection was classified as peritonitis or a pd catheter infection.The patient was still hospitalized, and no records were available from the patient¿s hospitalization.Subsequent attempts to obtain additional information were unsuccessful.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: PD (PERITONEAL DIALYSIS) CATHETER
• Type of Device: CATHETER, PERITONEAL, LONG-TERM INDWELLING
• MDR Report Key: 17352829
• MDR Text Key: 319426522
• Report Number: MW5119607
• 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: 07/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1