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

Device Problems Fluid/Blood Leak (1250); Appropriate Term/Code Not Available (3191); Material Split, Cut or Torn (4008)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

A peritoneal dialysis (pd) patient reported drain issue and reported a tear in the pd catheter and the catheter felt wet on the outside.Upon follow-up the peritoneal dialysis registered nurse {porn) stated the leak was observed from a hole in the patient's pd catheter and the patient cancelled treatment.It was confirmed there was no patient injury, no adverse effects were experienced, and no medical intervention was required as a result of the reported event.The patient was unable to complete treatment on the night of the reported event.The patient came into the clinic the same morning and had the pd catheter replaced.The porn confirmed there were no reported allegations that the leak was related to any issues with fresenius products.The patient was able to resume pd therapy the following evening without issue.The catheter used by the patient is not a fresenius device.The manufacturer of the catheter, 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: PD CATHETER
• Type of Device: CATHETER, PERITONEAL, LONG-TERM INDWELLING
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17528034
• MDR Text Key: 321271675
• Report Number: MW5134965
• 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: 06/30/2021

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