BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOWONIX DISTAL CATHETER SEGMENT

    MDR report key: 24246324 · Received February 2, 2026

    Report

    Report Number
    MW5183234
    Event Type
    Malfunction
    Date Received
    February 2, 2026
    Report Date
    January 29, 2026
    Manufacturer
    FLOWONIX MEDICAL INC/ INFUSYN THERAPEUTICS
    Product Code
    LKK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    A FLOWONIX DISTAL CATHETER SEGMENT AND CLEAR SHROUD WAS RETURNED WITHOUT ADDITIONAL INFORMATION. "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
    303497 FLOWONIX DISTAL CATHETER SEGMENT PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK FLOWONIX MEDICAL INC/ INFUSYN THERAPEUTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown