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

Catalog Number UNKNOWN PD CATHETER

Device Problem Positioning Problem (3009)

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

Event Date 07/30/2021

Event Type  Injury  

Event Description

On 27/jul/2021 the peritoneal dialysis registered nurse [(pd)rn] for this male pd patient reported that he was being assessed for a pd catheter (not a fresenius product) revision based on a kidney, ureter, bladder ultrasound showing it positioned incorrectly.Upon follow-up it was confirmed the patient underwent pd catheter revision surgery on (b)(6) 2021.There is no indication of a serious injury, patient death, or other adverse event related to a fresenius product or other issue.C-818408.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: 17533289
• MDR Text Key: 321149638
• Report Number: MW5140193
• 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: 08/10/2021

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
• Device Catalogue Number: UNKNOWN PD CATHETER
• Patient Sequence Number: 1