BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTROCAN SAFETY® 3

    MDR report key: 24400424 · Received February 20, 2026

    Report

    Report Number
    9610825-2026-00071
    Event Type
    Malfunction
    Date Received
    February 20, 2026
    Date of Event
    January 26, 2026
    Report Date
    February 20, 2026
    Manufacturer
    B BRAUN MELSUNGEN AG
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN INTERNAL REPORT NUMBER (B)(4). NO SAMPLE WAS PROVIDED FOR EVALUATION. BASED ON THE DATA FROM THE INVESTIGATION WE ARE UNABLE TO DETERMINE THE ROOT CAUSE OF THE REPORTED INCIDENT. THE REPORTED DEFECT WAS UNABLE TO BE CONFIRMED. DEVICE HISTORY RECORD (DHR): REVIEWED THE DHR FOR BATCH 22M10G8931, THERE IS NO ABNORMALITY AND NO SUCH DEFECT DETECTED DURING IN PROCESS AND FINAL CONTROL PRODUCT INSPECTION. 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, K182870, K213085.

    Description of Event or Problem · 0

    ACCORDING TO THE EVENT DESCRIPTION: DESCRIPTION OF EVENT: THE PATIENT WAS ADMITTED DUE TO "ESOPHAGEAL MALIGNANT TUMOR" ON (B)(6) 2026. ON (B)(6), ARTERIAL PUNCTURE WAS PLANNED. DURING THIS PERIOD, ARTERIAL PUNCTURE WAS PERFORMED USING SHIELDED I.V. CANNULA WITH INJECTION PORT DESIGNED TO MINIMIZE INADVERTENT NEEDLE STICKS AND UNIDENTIFIED BLACK OBJECT WAS FOUND IN THE INTRODUCER PUNCTURE NEEDLE DURING THIS PERIOD. IT WAS CONSIDERED TO BE CAUSED BY THE PRODUCT, AND A NEW SHIELDED I.V. CANNULA WITH INJECTION PORT DESIGNED TO MINIMIZE INADVERTENT NEEDLE STICKS WAS REPLACED IMMEDIATELY. THE REPLACEMENT WAS TIMELY AND DID NOT CAUSE SIGNIFICANT HARM TO THE PATIENT. DESCRIPTION OF ROOT CAUSE ANALYSIS (BY REPORTER): EXCLUDE THE PATIENT 'S OWN REASON, EXCLUDE THE NURSE' S OPERATION REASON, CONSIDER IT IS CAUSED BY THE PRODUCT, AND FIND UNIDENTIFIED BLACK OBJECT IN THE INTRODUCER PUNCTURE NEEDLE. PRELIMINARY HANDLING OF EVENT: RE-PUNCTURE IMMEDIATELY WITH SHIELDED I.V. CANNULA WITH INJECTION PORT DESIGNED TO MINIMIZE INADVERTENT NEEDLE STICKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    467332 INTROCAN SAFETY® 3 CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS FOZ B BRAUN MELSUNGEN AG 22M10G8931

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown