BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTROCAN SAFETY® 3

    MDR report key: 24049828 · Received January 12, 2026

    Report

    Report Number
    9610825-2025-00783
    Event Type
    Malfunction
    Date Received
    January 12, 2026
    Date of Event
    December 15, 2025
    Report Date
    January 15, 2026
    Manufacturer
    B BRAUN MELSUNGEN AG
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    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). COMPLAINT ANALYSIS: THE SITUATION DESCRIBED LEAKAGE ON PINK IV CANNULA INSERTED 12/13. WHEN REMOVED, THE TUBING IS SEEN TO BE BROKEN RIGHT NEXT TO THE ATTACHMENT. THE PRODUCT WAS DISCARDED. INVESTIGATION STATEMENT: NO SAMPLE RECEIVED BUT A PICTURE WAS PROVIDED. THE PICTURE SHOWS A USED INTROCAN SAFETY 3 20G WITH EVIDENCE OF BLOOD ALONG THE CAPILLARY TUBE. NO BROKEN TUBING CAN BE SEEN. OBSERVED THE CAPILLARY TUBE NEAR THE CATHETER HOUSING APPEARS KINKED BUT NO DROPLETS CAN BE SEEN. AS MENTIONED IN THE IFU, EXTREME CARE SHOULD BE TAKEN NOT TO DAMAGE, PIERCE, CUT OR SEVERE THE CATHETER. THEREFORE, DO NOT BEND THE CATHETER AND/OR NEEDLE DURING INSERTION, ADVANCEMENT, OR REMOVAL OF THE NEEDLE. DEVICE HISTORY RECORD (DHR): BATCH IS UNKNOWN, HENCE, UNABLE TO REVIEW THE DHR. REVIEWED ASSEMBLY PROCESS: THIS PRODUCT IS ASSEMBLED ON AUTOMATED ASSEMBLY MACHINES EQUIPPED WITH 100% VISION INSPECTION SYSTEM AND TEST STATIONS. PARTS FOUND OUT OF THE INSPECTION CRITERIA WILL BE DETECTED AND BE REJECTED AUTOMATICALLY BY MACHINE. AS THE BATCH IS UNKNOWN, WE COULD NOT REVIEW THE ASSEMBLY PROCESS CARDS. CONCLUSION: PICTURE SHOWS NO LEAKAGE OR BROKEN TUBING. HOWEVER, KINKED ON CAPILLARY NEAR HORN AREA WAS OBSERVED, WHICH COULD HAVE OCCURRED DURING INSERTION, ADVANCEMENT, OR REMOVAL OF THE NEEDLE AND MAY LEAD TO DAMAGE/RUPTURE AND POTENTIALLY CAUSE LEAKAGE. COMPLAINT IS 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.

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). THE INVESTIGATION IS ONGOING AT THIS TIME. A FOLLOW- UP WILL BE SUBMITTED WHEN THE INVESTIGATION RESULTS BECOME AVAILABLE. 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: "LEAKAGE ON PINK IV CANNULA INSERTED (B)(6) 13. WHEN REMOVED, THE TUBING IS SEEN TO BE BROKEN RIGHT NEXT TO THE ATTACHMENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    107833 INTROCAN SAFETY® 3 CATHETER,INTRAVASCULAR FOZ B BRAUN MELSUNGEN AG

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown