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

Device Problem Use of Device Problem (1670)

Patient Problems Bacterial Infection (1735); Peritonitis (2252)

Event Date 02/06/2023

Event Type  Injury  

Event Description

Rather, the nurse stated the peritonitis was due to an infected pd catheter (not a fresenius product) to which the bacteria developed biofilm on the catheter.The patient is having the catheter removed today and will be transitioned to hemodialysis for renal replacement needs.File #: (b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: PERITONEAL DIALYSIS (PD)
• Type of Device: CATHETER, PERITONEAL, LONG-TERM INDWELLING
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17488047
• MDR Text Key: 320687388
• Report Number: MW5120771
• 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: 06/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1