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

Device Problem Obstruction of Flow (2423)

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

Event Type  malfunction  

Event Description

A patient reported that they experienced a peritoneal dialysis (pd) catheter (not a fresenius product) surgery.The patient was experiencing drain complications and contacted fresenius technical support on (b)(6) 2020.During the call, the patient stated they were on hemodialysis (hd) for a while due to having pd catheter surgery.Upon follow up, the patient's peritoneal dialysis registered nurse (porn) confirmed that the patient was on hd due to issues with the patient's pd catheter.The patient did have pd catheter revision surgery; however, the problem has not resolved.The pd catheter was the cause of the drain complications reported to technical support on (b)(6) 2020.The porn stated this is an ongoing issue and there is no issue with the patient's liberty select cycler.(b)(6).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: 17528895
• MDR Text Key: 321364339
• Report Number: MW5135824
• 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: 11/03/2020

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