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

Device Problem Positioning Problem (3009)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

A peritoneal dialysis (pd) patient contacted fresenius technical support for draining issues while laying down.The draining issues are captured in a separate complaint file.The patient also stated they had their pd catheter (not a fresenius product) repositioned earlier that day.The patient's pd nurse confirmed the patient underwent a pd catheter manipulation on (b)(6) 2021.There was no indication of a serious injury, patient death, or other adverse event related to a fresenius product or other issue warranting further investigation.There was no allegation or objective evidence indicating a serious injury, patient death, or other serious adverse event(s) related to a fresenius device(s) or product(s) occurred warranting further investigation.(b)(4).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: 17534574
• MDR Text Key: 321414773
• Report Number: MW5141475
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1