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

Device Problems Complete Blockage (1094); Restricted Flow rate (1248)

Patient Problem Obstruction/Occlusion (2422)

Event Type  Injury  

Event Description

A peritoneal dialysis (pd) nurse reported that her patient e.H.Was admitted to the hospital recently because their peritoneal catheter was blocked and they could not drain the fluid.This catheter was not manufactured by fresenius medical care.The patient will most likely have to have the catheter repositioned to be able to resume their dialysis routine.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: CATHETER, PERITONEAL, LONG-TERM INDWELLING
• Type of Device: CATHETER, PERITONEAL, LONG-TERM INDWELLING
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17533668
• MDR Text Key: 321137644
• Report Number: MW5140572
• 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: 01/30/2020

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