BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTROCAN SAFETY® 3

    MDR report key: 24163148 · Received January 23, 2026

    Report

    Report Number
    9610825-2026-00006
    Event Type
    Malfunction
    Date Received
    January 23, 2026
    Date of Event
    November 27, 2025
    Report Date
    January 23, 2026
    Manufacturer
    B BRAUN MELSUNGEN AG
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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 EVENT OCCURRED AFTER THERAPY WHEN A RADIOGRAPHER WAS DECANNULATING A PATIENT, A PORTION OF THE TUBING WAS RETAINED IN THE VESSEL. INSTRUCTION FOR USE (IFU): PROPER ADHERENCE TO THE IFU MAY AVOID SUCH ISSUES. ACCORDING TO THE IFU UNDER THE WARNING SECTION, IT IS STATED THAT: AFTER WITHDRAWAL, DO NOT REINTRODUCE THE STEEL NEEDLE INTO THE CATHETER, AS THE LATTER MAY BE CUT OFF, LEADING TO CATHETER EMBOLISM. DO NOT BEND THE CATHETER/NEEDLE DURING INSERTION, ADVANCEMENT, OR REMOVAL OF THE NEEDLE. EXTREME CARE SHOULD BE TAKEN NOT TO CUT THE CATHETER AND POSSIBLY CAUSE AN EMBOLISM. EVIDENCE AT DISPOSAL: NO SAMPLES WERE RETURNED, AND NO MEANINGFUL PHOTOS AVAILABLE FOR A PROPER EVALUATION. DEVICE HISTORY RECORD (DHR): REVIEWED THE DEVICE HISTORY RECORD FOR BATCH NUMBER 25G09G8951 AND THERE WERE NO DEFECT ENCOUNTERED DURING IN PROCESS AND FINAL CONTROL PRODUCT INSPECTION. CONCLUSION: AS NO SAMPLE WAS RECEIVED, FURTHER INVESTIGATION WAS NOT POSSIBLE TO DETERMINE THE ACTUAL CAUSE. 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. 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, FOLLOWING COMPLETION OF THERAPY AND DURING DECANNULATION OF THE PATIENT, A PORTION OF THE DEVICE TUBING WAS RETAINED WITHIN THE PATIENT'S VESSEL. THE PATIENT WAS SUBSEQUENTLY SENT TO THE HOSPITAL FOR EVALUATION AND WAS AWAITING VASCULAR REVIEW AT THE TIME OF REPORTING. NO ADDITIONAL DETAILS REGARDING PATIENT OUTCOME HAVE BEEN MADE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228932 INTROCAN SAFETY® 3 CATHETER,INTRAVASCULAR FOZ B BRAUN MELSUNGEN AG 25G09G8951

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown