BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD CATHENA¿ SAFETY IV CATHETER

    MDR report key: 24130209 · Received January 21, 2026

    Report

    Report Number
    24130209
    Event Type
    Malfunction
    Date Received
    January 21, 2026
    Date of Event
    December 15, 2025
    Report Date
    December 29, 2025
    Manufacturer
    BECTON, DICKINSON AND COMPANY
    Product Code
    FOZ
    UDI-DI
    00382903868605
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    MULTIPLE 24G PIVS [PERIPHERAL INTRAVENOUS LINES] LEAKING DURING APPOINTMENTS IN OUTPATIENT INFUSION AT SITE WHERE PIV CONNECTS TO CATHETER EXTENSION SET. PIV DOES NOT LEAK WHEN CHECKING BLOOD RETURN BUT WHEN FLUSHING, PIV LEAKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    190307 BD CATHENA¿ SAFETY IV CATHETER CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS FOZ BECTON, DICKINSON AND COMPANY 386860 4311212 00382903868605

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown