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

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 07/26/2021

Event Type  malfunction  

Event Description

It was reported that a peritoneal dialysis (pd) patient had a permcath (not a fresenius product) inserted.Subsequent attempts to obtain additional information (e.G., discharge summary, patient demographics, treatment data) have thus far proven unsuccessful.Based on the limited information available, there is no allegation or objective evidence indicating a serious injury, patient death, or other serious adverse event(s) related to a fresenius device(s) and/or product(s) occurred warranting further investigation.The catheter used by the patient is not a fresenius device.The manufacturer of the catheter, and further product information, is unknown.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: PERITONEAL DIALYSIS CATHETER
• Type of Device: CATHETER, PERITONEAL, LONG-TERM INDWELLING
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17526688
• MDR Text Key: 321408878
• Report Number: MW5133626
• 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: 08/09/2021

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: 08/12/2023
• Patient Sequence Number: 1