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

Device Problems Malposition of Device (2616); Improper Flow or Infusion (2954)

Patient Problem Pain (1994)

Event Type  Injury  

Event Description

A patient on peritoneal dialysis (pd) reported experiencing a drain complication during pd treatment with the fresenius cycler.It was also reported the patient was feeling pain in drain phase due to recently having surgery.There were no recorded injures as a result of the reported event.In additional follow-up, the pd nurse reported the patient had the pd catheter (not a fresenius product) manipulated due to malposition pd catheter which was causing the patient some drain issues.The nurse confirmed the cycler did not cause pain and this was related to the patient's pd catheter.The nurse stated the patient did not have any adverse effects from use of any fresenius device, or product.(b)(4).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: 17534960
• MDR Text Key: 321151359
• Report Number: MW5141860
• 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: 04/02/2021

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
• Patient Sequence Number: 1