MAUDE Adverse Event Report: UNKNOWN CATHETER, PERITONEAL

Device Problem Fluid/Blood Leak (1250)

Patient Problem Myocardial Infarction (1969)

Event Type  Death  

Event Description

This is a report from a caregiver (cg) of a home patient (hp) that contacted baxter to report that the hp had passed away.The hp had experienced issues with draining and was hospitalized due to the peritoneal dialysis catheter leaking fluid into the subcutaneous tissue.The cause of the leak was unknown.This was related to the catheter which is not a baxter product.The cause of death listed on the hp's death certificate was myocardial infarction.Product surveillance contacted the nurse to obtain catheter manufacturer information.The nurse stated that she did not know the manufacturer of the catheter.No further information was provided.Patient injury reported: yes (b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: CATHETER, PERITONEAL
• Type of Device: CATHETER, PERITONEAL
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17529798
• MDR Text Key: 321041678
• Report Number: MW5136721
• 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: 06/27/2013

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