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

Device Problems Suction Problem (2170); Positioning Problem (3009)

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

Event Date 07/26/2021

Event Type  Injury  

Event Description

It was reported that a peritoneal dialysis (pd) patient had surgery to reposition the catheter.Upon follow up with the patient's pdrn, it was reported this patient underwent a nonemergent outpatient procedure to remove omentum that was wrapped around his pd catheter (not a fresenius product).The patient experienced drain complications during ccpd therapy on the liberty select cycler at home prior to this event.The patient was not hospitalized and recovered from the procedure.It was confirmed the patient's omentum wrapped pd catheter, and the associated outpatient procedure were not due to a deficiency or malfunction of any fresenius product(s) or device(s).The patient continues ccpd therapy on a newly received liberty select cycler at home.Based on the required information there is no indication of a serious injury, patient death, or other adverse event related to a fresenius product or other issue warranting further investigation.The catheter used by the patient is not a fresenius device.The manufacturer of the cathete.R, and further product information, is unknown.(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: 17533942
• MDR Text Key: 321163867
• Report Number: MW5140845
• 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: 08/05/2021

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