MAUDE Adverse Event Report: UNKNOWN PD CATHETER; CATHETER, PERITONEAL

Device Problems Burst Container or Vessel (1074); Fluid/Blood Leak (1250)

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

Event Type  malfunction  

Event Description

A peritoneal dialysis (pd) patient reported that the tubing from their catheter burst and leaked fluid.The patient reported that they patched up the tubing.The patient was advised to contact their peritoneal dialysis registered nurse for assistance.Upon follow up, the patient stated they are trained on performing stat drains, as well as manual peritoneal dialysis therapy if needed.The patient reported that the fluid leaked on their mattress and it occurred from the catheter insert site that connects to their body.The patient stated that the fluid leak did not come in contact with the cycler.The patient stated that they tore the plastic part on the catheter and reattached it back to themselves and then continued treatment.The patient did not develop any symptoms, adverse events, injuries, or require medical intervention as a result of the reported event.The patient is continuing peritoneal dialysis therapy with no further issues.The catheter insert site used by the patient is not available for return for physical evaluation by the manufacturer.(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
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17523245
• MDR Text Key: 321368235
• Report Number: MW5130193
• Device Sequence Number: 1
• Product Code: GBW
• 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: 12/24/2020

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