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

Device Problem Fluid/Blood Leak (1250)

Patient Problem Hemorrhage/Bleeding (1888)

Event Type  malfunction  

Event Description

Patient (b)(6) reported blood in the cassette lines and drain bag during therapy.The patient was new to pd therapy and recently had the pd catheter, not manufactured by fresenius, inserted.The blood in the lines was due to the newness of the catheter.The patient is continuing pd therapy with no further issues.Ni.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: 17526282
• MDR Text Key: 321325150
• Report Number: MW5133221
• 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: 05/01/2018

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