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

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Abdominal Pain (1685)

Event Type  Injury  

Event Description

During follow-up for a separate event, this patient on peritoneal dialysis (pd) reported not draining and having lower abdominal pain resulting in surgery on (b)(6) 2022.It was stated the pd catheter had skin growing around it.In additional follow-up, the patient's pd nurse stated the patient was having some abdominal pain related to pd catheter (not a fresenius product) malfunction.The nurse confirmed that on (b)(6) 2022, the patient had pd catheter repositioning removal of omentum wrapping on the catheter.The nurse confirmed the patient's pd catheter migration and becoming wrapped in omentum was causing the patient's reported drain issue.The nurse confirmed the patient did not have any adverse effects from use of any fresenius products and continues pd treatment on the fresenius cycler without any issues.(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: 17488345
• MDR Text Key: 320690887
• Report Number: MW5121043
• 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: 12/07/2022

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: 08/09/2023
• Patient Sequence Number: 1