BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIPRO IV CATHETER

    MDR report key: 23386883 · Received October 25, 2025

    Report

    Report Number
    9610987-2025-00026
    Event Type
    Malfunction
    Date Received
    October 25, 2025
    Date of Event
    September 26, 2025
    Report Date
    October 25, 2025
    Manufacturer
    NIPRO CORPORATION (ODT)
    Product Code
    FOZ
    PMA / PMN Number
    K960051
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE CATHETER WAS ADVANCED AFTER PUNCTURE, BUT IT WOULD NOT GO IN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1790505 NIPRO IV CATHETER CATHETER FOZ NIPRO CORPORATION (ODT) NUC-24X1 24K22C

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other