BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTROCAN SAFETY® 3

    MDR report key: 24163147 · Received January 23, 2026

    Report

    Report Number
    9610825-2026-00008
    Event Type
    Malfunction
    Date Received
    January 23, 2026
    Date of Event
    December 1, 2025
    Report Date
    January 23, 2026
    Manufacturer
    B BRAUN MELSUNGEN AG
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). DEVICE HISTORY RECORD (DHR): REVIEWED THE DEVICE HISTORY RECORD FOR BATCH NUMBER 25D24G8931 AND THERE WERE NO DEFECT ENCOUNTERED DURING IN PROCESS AND FINAL CONTROL PRODUCT INSPECTION. EVIDENCE AT DISPOSAL: NO ACTUAL SAMPLE WAS RETURNED TO BMI FOR INVESTIGATION. RECEIVED 6 PCS OF PICTURES AND A VIDEO FROM THE CUSTOMER. INVESTIGATION WILL BE CARRIED OUT BASED ON PICTURES AND VIDEO ATTACHED. INVESTIGATION STATEMENT: FROM THE PICTURES AND VIDEO, OBSERVED THE ROLLER CLAMP WAS IN CLAMPED POSITION (CLOSED) WHICH BLOCKED THE SOLUTION IN THE TUBING TO FLOW. BESIDES, THE CONNECTION BETWEEN EXTENSION CONNECTOR AND CATHETER HUB PUSHED THE SEPTUM OPENER, CAUSING THE VALVE TO OPEN. WHEN THE EXTENSION CONNECTOR IS ATTACHED (CONNECTED) TO THE CATHETER HUB, THE CONNECTOR PRESSES AGAINST THE SEPTUM OPENER. THIS PRESSURE PUSHED THE VALVE IN THE CATHETER HUB INTO AN OPEN POSITION. AS RESULT, THE VALVE REMAINED OPENED AND ALLOWS THE BACKFLOW TO OCCUR. SINCE THE SOLUTION IN TUBING WAS NOT FLOWING INTO THE VEINS, THIS CREATED THE DIFFERENT PRESSURE THAT CAUSED BLOOD FROM PATIENT'S VEINS TO BACKFLOW INTO TUBING. THIS PHENOMENON IS COMMON WHEN THE IV TUBING IS CLAMPED (THE SOLUTION WAS NOT FLOWING) AND THE VALVE IN OPENED CONDITION. ASSEMBLY PROCESS CARD WAS REVIEWED. NO ABNORMALITY DURING MANUFACTURING OF THE COMPLAINT BATCH. THEREFORE, THIS COMPLAINT IS CONCLUDED AS NOT CONFIRMED. NOTE: THIS REPORT 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: PREMARKET SUBMISSION # K213085.

    Description of Event or Problem · 0

    ACCORDING TO THE COMPLAINANT, TWO ISSUES WERE IDENTIFIED WITH INTROCAN SAFETY 3 DEVICES FROM A SINGLE LOT. DURING CATHETER INSERTION, BLOOD LEAKAGE WAS OBSERVED DESPITE REMOVAL OF THE TOURNIQUET PRIOR TO NEEDLE WITHDRAWAL AND THE NEEDLE BEING WITHDRAWN STRAIGHT AFTER INSERTION. IN A SEPARATE OBSERVATION INVOLVING THE SAME LOT, AFTER CONNECTING THE CATHETER TO THE INFUSION SET, BLOOD REFLUXED INTO THE IV TUBING APPROXIMATELY TWO (2) MINUTES AFTER INITIATION OF THE INFUSION, DESPITE USING AN INTRAFIX SAFESET AND CLAMPING OF THE ROLLER CLAMP. NO PATIENT INJURY OR ADVERSE CLINICAL OUTCOMES WERE REPORTED AS A RESULT OF THESE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228935 INTROCAN SAFETY® 3 CATHETER,INTRAVASCULAR FOZ B BRAUN MELSUNGEN AG 25D24G8931

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown