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

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

Patient Problem Unspecified Infection (1930)

Event Date 05/19/2020

Event Type  malfunction  

Event Description

On (b)(6) 2020, a patient on peritoneal dialysis (pd) reported having a pd catheter (not a fresenius product) exit site infection on (b)(6) 2020.It was reported the patient had a 21-day course of antibiotics.The patient stated the infection was unrelated to the use of any fresenius product(s) or device(s).The patient's nurse reported the infection was caused by moisture at the exit site.During additional follow-up, the patient confirmed the event.Based on the available information, there is no allegation or indication that a fresenius device or product issue caused or contributed to a serious patient harm or injury.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: PERITONEAL DIALYSIS (PD) CATHETER
• Type of Device: CATHETER, PERITONEAL, LONG-TERM INDWELLING
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17531647
• MDR Text Key: 321405805
• Report Number: MW5138560
• 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: 08/03/2020

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