BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTROCAN SAFETY® 3

    MDR report key: 23553841 · Received November 14, 2025

    Report

    Report Number
    9610825-2025-00666
    Event Type
    Malfunction
    Date Received
    November 14, 2025
    Report Date
    November 14, 2025
    Manufacturer
    B BRAUN MELSUNGEN AG
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). DEVICE HISTORY RECORD (DHR): UNABLE TO REVIEW THE DEVICE HISTORY RECORD AS BATCH IS UNKNOWN. EVIDENCE AT DISPOSAL: NO SAMPLES RETURNED AND NO PHOTOS PROVIDED FOR A PROPER ANALYSIS. REVIEWED ASSEMBLY PROCESS CARDS: THIS PRODUCT IS ASSEMBLED ON AUTOMATED ASSEMBLY MACHINES EQUIPPED WITH 100% VISION INSPECTION SYSTEM AND TEST STATIONS. ALONG THE MACHINES, THERE IS VALVE LEAKAGE TEST STATION. THIS TEST SPECIFICALLY ASSESSES THE VALVE'S CAPABILITY TO RETAIN THE PRESSURE BY APPLYING A CONTROLLED PRESSURE AND MONITORING FOR ANY LEAKAGE OR PRESSURE DIFFERENTIAL. ANY UNIT FAILING TO MEET THE STRINGENT CRITERIA OF THIS VALVE LEAKAGE TEST IS AUTOMATICALLY DETECTED AND WILL BE REJECTED AUTOMATICALLY AT THE UNLOAD REJECT PARTS STATION, PREVENTING ITS PROGRESSION TO SUBSEQUENT MANUFACTURING STAGES. CONCLUSION: AS NO SAMPLE WAS RECEIVED, FURTHER INVESTIGATION WAS NOT POSSIBLE. COMPLAINT IS NOT CONFIRMED. NOTE: THIS REPORTED IS BEING FILED FOR AN ITEM NUMBER THAT IS NOT SOLD IN THE UNITED STATES, HOWEVER SIMILAR ITEMS ARE SOLD IN THE UNITED STATES BY B. BRAUN MEDICAL, INC. PLEASE NOTE, THIS DEVICE IS DISTRIBUTED OUTSIDE THE US AND NO GUDID INFORMATION EXISTS. IT IS BEING REPORTED DUE TO A SIMILAR DEVICE BEING MARKETED WITHIN THE US WITH THE FOLLOWING INFO: UDI NUMBER (B)(4) PREMARKET SUBMISSION # K111236.

    Description of Event or Problem · 0

    ACCORDING TO THE EVENT DESCRIPTION: "I HAVE BEEN INVOLVED IN A PATIENT INCIDENT RECENTLY WHERE A PATIENT HAD BLOOD BACKFLOW THROUGH THE CANNULA AND GRAVITY ADMIN SET, LOOSING QUITE A LARGE VOLUME OF BLOOD. I WAS OF THE UNDERSTANDING THAT THE INTROCAN SAFETY 2 CANNULAS HAS THE SEPTUM TO PREVENT SOMETHING LIKE THIS FROM HAPPENING?"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1922921 INTROCAN SAFETY® 3 CATHETER,INTRAVASCULAR FOZ B BRAUN MELSUNGEN AG

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown