BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTROCAN SAFETY® 3

    MDR report key: 24049831 · Received January 12, 2026

    Report

    Report Number
    9610825-2026-00001
    Event Type
    Malfunction
    Date Received
    January 12, 2026
    Date of Event
    October 17, 2025
    Report Date
    January 12, 2026
    Manufacturer
    B BRAUN MELSUNGEN AG
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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 REVIEW (DHR): UNABLE TO REVIEW THE DEVICE HISTORY RECORD AS BATCH IS UNKNOWN. RECEIVED A POSSIBLE BATCH 20N25G8371, THIS BATCH WAS REVIEWED AND NO ABNORMALITIES FOUND DURING IN PROCESS AND FINAL CONTROL INSPECTION. SAMPLE FOR EVALUATION: RECEIVED 1 PIECE OF USED AND CONTAMINATED CATHETER HUB SAMPLE OF INTROCAN SAFETY 3 PUR 24G 0.7X19MM-JP. VISUAL INSPECTION: OBSERVED DAMAGE ON THE CATHETER HUB INNER LUER UNDER 20X MAGNIFICATION OF KEYENCE MICROSCOPE. THE DAMAGE COULD BE THE CONTRIBUTING FACTOR TO LUER LOCK LEAKAGE. NO DAMAGE WAS OBSERVED ON THE RETURNED EXTENSION SET UNDER 20X MAGNIFICATION OF KEYENCE MICROSCOPE. SIMULATION TO TEST FOR LEAK: THE RETURNED CATHETER HUB SAMPLE WAS CONNECTED WITH THE RETURNED EXTENSION SET AND FLUSHED WITH RED DYE SOLUTION USING LUER LOCK SYRINGE TO CHECK FOR ANY LEAKAGE. RESULT: NO LEAKAGE WAS OBSERVED ON THE ENTIRE PIECE OF RETURNED CATHETER HUB SAMPLE DURING INVESTIGATION. LEAKAGE TEST: SAMPLE WAS SUBJECTED TO AIR TIGHTNESS 300KPA/30S (3BAR/30S) ACCORDING TO TEST METHOD. RESULT: NO AIR BUBBLES OR LEAKAGE WAS OBSERVED. THE RETURNED CONTAMINATED SAMPLE PASSED THE TEST. INVESTIGATION RESULTS: BASED ON PREVIOUS INVESTIGATION, THE DENTED HUB COULD BE DUE TO SEPTUM OPENER PIN BEND DUE TO THE MATERIAL PROPERTY OF THE PIN AND SLIGHT MOVEMENT OF THE GRIPPER AFTER REACHED THE SET POSITION. THIS COMPLAINT IS CONCLUDED AS CONFIRMED DUE TO DEFECT OBSERVED. CORRECTIVE MEASURES ALREADY IMPLEMENTED, THIS COMPLAINT IS 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: UDI NUMBER (B)(4) PREMARKET SUBMISSION # K111236.

    Description of Event or Problem · 0

    ACCORDING TO THE EVENT DESCRIPTION: "COMPLAINT: AS THE PRODUCT WAS USED WITH EXTENTION TUBE, LEAKAGE FROM CONNECTION PART WAS OBSERVED. NO IMPROVEMENT WAS OBSERVED AFTER EXHANGING THE EXTENTION TUBE, BUT AS EXCHANGING INTROCAN TO THE NEW ONE, IT WAS IMPROVED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108037 INTROCAN SAFETY® 3 CATHETER,INTRAVASCULAR FOZ B BRAUN MELSUNGEN AG 20N25G8371

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown