BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PD CATHETER

    MDR report key: 23920826 · Received December 29, 2025

    Report

    Report Number
    MW5181371
    Event Type
    Malfunction
    Date Received
    December 29, 2025
    Date of Event
    October 30, 2025
    Report Date
    December 17, 2025
    Manufacturer
    UNKNOWN
    Product Code
    FJS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    PLEASE NOTE THE ATTACHED COMPLAINT INVOLVES A DEVICE ASSOCIATED WITH AN ADVERSE EVENT THAT IS NOT MANUFACTURED BY FRESENIUS MEDICAL CARE NORTH AMERICA. A PERITONEAL DIALYSIS (PD) PATIENT (PT) CONTACTED FRESENIUS TECHNICAL SUPPORT TO REPORT HE RECENTLY HAD SURGERY TO REPLACE CATHETER. SPOKE WITH PD NURSE (B)(6) FROM (B)(6) ON (B)(6) 2025 AT 5:15 PM CST AT (B)(6) AND WAS ABLE TO CONFIRM THAT THE PATIENT HAD SURGERY ON (B)(6), DURING WHICH THE CATHETER WAS REPLACED. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2197439 PD CATHETER CATHETER, PERITONEAL, LONG-TERM INDWELLING FJS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown