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

Device Problems Migration or Expulsion of Device (1395); Malposition of Device (2616)

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

Event Type  Injury  

Event Description

On (b)(6) 2021, fresenius became aware this 38-year-old female patient with end stage renal disease (esrd) on continuous cyclic peritoneal dialysis [cc(pd)] for renal replacement therapy (rrt) underwent a pd catheter (not a fresenius product) revision.Follow-up with the patient's pd registered nurse (porn}, confirmed the patient successfully underwent an outpatient pd catheter (not a fresenius product) revision on (b)(6) 2021 due to a mal positioning.Radiological studies revealed the patient's pd catheter migrated out of the proper position and would require surgical correction.The patient was released several hours later in stable condition, and they resumed ccpd at home utilizing the same liberty select cycler as before the event(s).Per the porn, the event was unrelated to the utilization of any fresenius device(s) and/or product(s).(b)(6), ce00112521.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: 17523821
• MDR Text Key: 321133186
• Report Number: MW5130769
• 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: 08/24/2021

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