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

Device Problem Infusion or Flow Problem (2964)

Patient Problem Fungal Infection (2419)

Event Date 10/01/2022

Event Type  Injury  

Event Description

While hospitalized, the patient encountered drain complications (prior to culture results) and it was discovered the patient had a fungal (yeast) infection of his pd catheter (not a fresenius product).The patient underwent the surgical removal of the pd catheter (timeline not provided) and insertion of a permanent "tunneled" hemodialysis (hd) catheter.(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, LONG-TERM INDWELLING
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17488349
• MDR Text Key: 320689899
• Report Number: MW5121048
• 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: 12/05/2022

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: 08/09/2023
• Patient Sequence Number: 1