PERITONEAL DIALYSIS CATHETER

Report

• Report Number: MW5179956
• Event Type: Injury
• Date Received: December 4, 2025
• Report Date: December 2, 2025
• Manufacturer: UNKNOWN
• Product Code: FKO
• Adverse Event: Yes
• Report Source: Voluntary report
• Reporter Location: MA, US
• Reporter Occupation: UNKNOWN
• Health Professional: *

Narratives

Description of Event or Problem · 0

A PERITONEAL DIALYSIS (PD) PATIENT REPORTED TO (B)(6) CUSTOMER SERVICE THAT THEY WERE IN THE HOSPITAL DUE TO AN INFECTION AT THEIR PD CATHETER SITE. NO ADDITIONAL INFORMATION WAS PROVIDED IN THE INITIAL REPORTING. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION, AND THUS FAR NO FURTHER DETAILS HAVE BEEN PROVIDED. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
2822308	PERITONEAL DIALYSIS CATHETER	CATHETER, PERITONEAL DIALYSIS, SINGLE USE	FKO	UNKNOWN

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Unknown

Terms

Patient problem · 1

• Unspecified Infection

Product problems · 1

• Patient Device Interaction Problem

Type of report · 1

• Initial submission