BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERITONEAL DIALYSIS CATHETER

    MDR report key: 23606120 · Received November 20, 2025

    Report

    Report Number
    MW5179169
    Event Type
    Injury
    Date Received
    November 20, 2025
    Report Date
    November 17, 2025
    Manufacturer
    UNK
    Product Code
    FKO
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED TO (B)(6)THAT A PERITONEAL DIALYSIS (PD) PATIENT WAS HOSPITALIZED DUE TO PD CATHETER (NOT A (B)(6) PRODUCT) ISSUES. FOLLOW-UP WITH THE PATIENT¿S PD REGISTERED NURSE (PDRN) REVEALED THE PATIENT HAD NOT BEGUN PERFORMING PD THERAPY, AS THE PD CATHETER (NOT A (B)(6) PRODUCT) BECAME INFECTED PRIOR TO BEGINNING TRAINING. THE PATIENT WAS HOSPITALIZED ON (B)(6) 2025 DUE TO THE PD CATHETER INFECTION, AND WAS STARTED ON ANTIBIOTICS (DRUGS, DOSAGES, FREQUENCIES, DURATIONS, ROUTES NOT PROVIDED). THE PATIENT¿S PD CATHETER WAS REMOVED, AND A HEMODIALYSIS (HD) CATHETER WAS SIMULTANEOUSLY PLACED. THE PATIENT WILL REMAIN ON HD UNTIL THE INFECTION HAS CLEARED. THE PDRN ATTRIBUTED CAUSALITY TO AN UNSPECIFIED TOUCH CONTAMINATION EVENT. PER THE PDRN, THE SERIOUS ADVERSE EVENTS WERE NOT CAUSED BY ANY (B)(6) PRODUCT(S) AND/OR DEVICE(S). 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
    2076993 PERITONEAL DIALYSIS CATHETER CATHETER, PERITONEAL DIALYSIS, SINGLE USE FKO UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown