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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Pain (1994)

Event Date 01/01/2020

Event Type  Injury  

Event Description

It was reported that a dialysis patient had a peritoneal dialysis (pd) catheter placed that caused a very painful severe infection before it was used for treatment.The patient was hospitalized and the catheter was removed.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: PERITONEAL DIALYSIS CATHETER
• Type of Device: CATHETER, PERITONEAL, LONG-TERM INDWELLING
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17525023
• MDR Text Key: 321145849
• Report Number: MW5131965
• 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: 03/22/2022

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