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

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

It was reported that a patient on continuous cyclic peritoneal dialysis [cc(pd)] therapy required a pd catheter (not a fresenius product) revision on (b)(6) 2020.Additional details were uncovered during follow up with the patient's peritoneal dialysis registered nurse (porn).The pd catheter revision occurred one week into continuous ambulatory pd (capd) training.Therefore, the patient was not trained, nor in possession of a liberty select cycler during that time.Upon review of the available information, there is no allegation, indication or objective evidence a serious patient injury, death, or other adverse event(s) was associated with the use of a fresenius medical device(s).Additionally, there was no evidence a malfunction or deficiency of a fresenius medical device occurred.(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: 17536459
• MDR Text Key: 321181544
• Report Number: MW5143347
• 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: 11/27/2020

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