BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTROCAN SAFETY 3 CLOSED IV CATH

    MDR report key: 22106285 · Received May 29, 2025

    Report

    Report Number
    MW5170880
    Event Type
    Malfunction
    Date Received
    May 29, 2025
    Report Date
    May 21, 2025
    Manufacturer
    B. BRAUN MEDICAL INC.
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PERIPHERAL IV PLACED FOR OUTPATIENT INFUSION TX. IV PLACED AND CONFIRMED TO FLUSH AND HAVE BLOOD RETURN AT TIME OF PLACEMENT. WHEN TRYING TO USE THE IV FOR TREATMENT 30 MINUTES LATER, IV IS NON-PATENT, WILL NOT FLUSH, AND WILL NOT DRAW BACK BLOOD. THE VALVE WITHIN THE IV CATHETER ITSELF SEEMS TO HAVE STOPPED WORKING; THE MICROCLAVE CLEAR NEUTRAL CONNECTOR WAS REPLACED, WHICH DID NOT FIX THE PROBLEM. IV CATHETER WAS A 24-GAUGE B-BRAUN INTROCAN SAFETY 3 CLOSED IV CATHETER (REF #4251127-02, LOT# 24M26G8952).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36251 INTROCAN SAFETY 3 CLOSED IV CATH CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS FOZ B. BRAUN MEDICAL INC. 24M26G8952

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Female