BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTROCAN SAFETY® 3

    MDR report key: 23222656 · Received October 6, 2025

    Report

    Report Number
    9610825-2025-00591
    Event Type
    Injury
    Date Received
    October 6, 2025
    Date of Event
    September 5, 2025
    Report Date
    October 6, 2025
    Manufacturer
    B BRAUN MELSUNGEN AG
    Product Code
    FOZ
    Adverse Event
    Yes
    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 MEDICAL INTERNAL REPORT NUMBER (B)(4). DEVICE HISTORY RECORD (DHR): REVIEWED THE DEVICE HISTORY RECORD AND THERE WERE NO DEFECT ENCOUNTERED DURING IN PROCESS AND FINAL CONTROL INSPECTION. MANUFACTURING CONTROL: PRODUCTS ARE SUBJECTED TO IN-PROCESS QUALITY CONTROLS AND FINAL CONTROLS INSPECTION BASED ON RANDOM SAMPLES BASIS WHICH HAS BEEN CONDUCTED BY DIFFERENT TEAMS ON A REGULAR BASIS WITHIN THE PRODUCTION PROCESS TO ENSURE THE PRODUCT ARE FREE FROM ANY DAMAGES. HEREWITH A SYSTEMATIC PRODUCT DEFECT WOULD BE DETECTED. INVESTIGATION STATEMENT: THE PROCESS MAPPING OF END CONTROL MACHINE (ECM) FOR THIS PRODUCT HAS BEEN REVIEWED. IF THERE IS A DAMAGE IN THE FORM OF TEAR AT THE CAPILLARY TIP AREA, IT SHALL BE DETECTED DURING THE "TRIM LENGTH, BEVEL & CONTOUR CHECKING" VISION INSPECTION STATION. A DAMAGE CATHETER TIP WILL APPEAR ERROR FOR ITS TRIM LENGTH AND WILL BE REJECTED. INSTRUCTION FOR USE (IFU) REVIEW 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. CONCLUSION: AS NO SAMPLE WAS RECEIVED, FURTHER EVALUATION WAS NOT POSSIBLE TO DETERMINE THE ACTUAL CAUSE. COMPLAINT IS NOT CONFIRMED. NOTE: THIS REPORTED 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: "ON (B)(6) 2025, THE PATIENT NEEDED INTRAVENOUS INFUSION DUE TO DISEASE CONDITION AND UNDERWENT INDWELLING NEEDLE PUNCTURE IN THE EMERGENCY SURGERY DEPARTMENT. ON THE SECOND DAY AFTER ADMISSION, IT WAS FOUND THAT THE HOSE IN THE FRONT SEGMENT OF INDWELLING NEEDLE WAS MISSING BY 1 CM, AND THE PATIENT HAD NO DISCOMFORT. BEDSIDE EMERGENCY COLOR DOPPLER ULTRASOUND WAS PERFORMED, AND EMERGENCY SURGICAL FOREIGN BODY REMOVAL WAS PERFORMED IN CONTACT WITH THE DEPARTMENT OF VASCULAR SURGERY. NO BROKEN END HOSE WAS OBSERVED DURING THE PROCEDURE. LATER, THE DEPARTMENT OF INTERVENTIONAL MEDICINE WAS INVITED FOR CONSULTATION, AND THE CONSULTATION OPINIONS SUGGESTED THAT INTERVENTIONAL THERAPY WAS NOT RECOMMENDED AT THE CURRENT STAGE, AND FOLLOW-UP EXAMINATIONS WERE PERFECTED. SINCE THE EVENT OCCURRED, THE DEPARTMENT AND FAMILY MEMBERS HAVE FULLY COMMUNICATED AND CLOSELY OBSERVED THE CHANGES IN THE PATIENT 'S CONDITION, AND THE PATIENT DID NOT RESPOND TO DISCOMFORT SYMPTOMS. DESCRIPTION OF ROOT CAUSE ANALYSIS (BY REPORTER): THE HOSE WAS FOUND TO BE SIGNIFICANTLY SHORTER THAN NORMAL AFTER PULLING OUT, AND 1 CM WAS MISSING FROM THE FRONT END AFTER COMPARISON. PRELIMINARY HANDLING OF EVENT: BEDSIDE EMERGENCY COLOR DOPPLER ULTRASOUND WAS PERFORMED, AND EMERGENCY SURGICAL FOREIGN BODY REMOVAL WAS PERFORMED IN CONTACT WITH THE DEPARTMENT OF VASCULAR SURGERY. NO BROKEN END HOSE WAS OBSERVED DURING THE PROCEDURE. LATER, THE DEPARTMENT OF INTERVENTIONAL MEDICINE WAS INVITED FOR CONSULTATION, AND THE CONSULTATION OPINIONS SUGGESTED THAT INTERVENTIONAL THERAPY WAS NOT RECOMMENDED AT THE CURRENT STAGE, AND FOLLOW-UP EXAMINATIONS WERE PERFECTED. SINCE THE EVENT OCCURRED, THE DEPARTMENT AND FAMILY MEMBERS HAVE FULLY COMMUNICATED AND CLOSELY OBSERVED THE CHANGES IN THE PATIENT 'S CONDITION, AND THE PATIENT DID NOT RESPOND TO DISCOMFORT SYMPTOMS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2575819 INTROCAN SAFETY® 3 CATHETER,INTRAVASCULAR FOZ B BRAUN MELSUNGEN AG 25A23G8371

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention