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

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Hemorrhage/Bleeding (1888)

Event Type  Injury  

Event Description

A peritoneal dialysis (pd) patient underwent pd catheter (not a fresenius product) replacement a few months ago.The nurse states the patient is bleeding from the inside of the pd catheter and will be seeing a surgeon this week for this issue.The nurse confirmed the patient did not have any adverse effects from use of any fresenius device, product or drug.The patient continues pd treatment with the same cycler without adverse effects.(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: 17534183
• MDR Text Key: 321149709
• Report Number: MW5141086
• 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: 06/14/2021

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