MAUDE Adverse Event Report: UNKNOWN CATHETER, PERITONEAL

Device Problem Material Protrusion/Extrusion (2979)

Patient Problem Peritonitis (2252)

Event Type  Injury  

Event Description

It was reported that the patient experienced peritonitis coincident with peritoneal dialysis (pd) therapy.The patient was hospitalized for the event.Treatment was unknown.On an unknown date while the patient was still hospitalized, the pd catheter was removed and the patient was switched to hemo dialysis.Cause of peritonitis was pd catheter cuff extrusion.Product surveillance spoke with the peritoneal dialysis nurse (pdrn) who stated that she does not have the information about the catheter, including the manufacturer.This information is unknown.No further information was provided.Patient injury reported: yes.Medical intervention required: 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: 17536276
• MDR Text Key: 321153740
• Report Number: MW5143166
• 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: 03/22/2013

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