BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTROCAN SAFETY ® 2

    MDR report key: 22838940 · Received August 19, 2025

    Report

    Report Number
    9610825-2025-00471
    Event Type
    Malfunction
    Date Received
    August 19, 2025
    Date of Event
    July 25, 2025
    Report Date
    August 19, 2025
    Manufacturer
    B BRAUN MELSUNGEN AG
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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). THE SITUATION DESCRIBED NURSES NOTICED A LEAK FROM THE CATHETER 24 HOURS AFTER INSERTION. THIS LED TO THE REMOVAL AND INSERTION OF A NEW DEVICE. UNABLE TO REVIEW THE DEVICE HISTORY RECORD AS BATCH IS UNKNOWN. NO SAMPLE RECEIVED AND NO MEANINGFUL PHOTOS AVAILABLE FOR A PROPER EVALUATION. THIS PRODUCT IS ASSEMBLED ON AUTOMATIC ASSEMBLY MACHINES EQUIPPED WITH 100% VISION INSPECTION SYSTEM AND TEST STATIONS. ALONG THE MACHINES, THERE IS CATHETER LEAKAGE TEST STATION WHERE AIR PRESSURE IS SUBJECTED TO THE CATHETER HUB WITH THE ASSEMBLED CAPILLARY AND METAL BUSH INSIDE. A DEFECT CATHETER HUB, RELATED TO THE LEAKAGE WOULD CREATE GAPS THAT WOULD ALLOW AIR TO ESCAPE, WHICH WILL CAUSE THE PRESSURE TO EXCEED THE ALLOWED TEST PRESSURE RANGE. THE DEFECTIVE PART WILL BE AUTOMATICALLY REJECTED AND REMOVED AT THE REJECT PART STATION AND WILL NOT PROCEED TO THE PROCESS. BESIDES THE IN-LINE TEST EQUIPMENT, PRODUCTS ARE SUBJECTED TO IN-PROCESS QUALITY CONTROLS AND FINAL CONTROLS INSPECTION BASED ON A RANDOM SAMPLE BASIS. HEREWITH A SYSTEMATIC PRODUCT DEFECT WOULD BE DETECTED. AS NO SAMPLE WAS RECEIVED, FURTHER INVESTIGATION WAS NOT POSSIBLE. COMPLAINT IS NOT CONFIRMED. THIS COMPLAINT HAS BEEN ADDED INTO THE STATISTIC FOR TREND ANALYSIS. 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).

    Description of Event or Problem · 0

    ACCORDING TO THE EVENT DESCRIPTION: "THE NURSES NOTICED A LEAK FROM THE CATHETER 24 HOURS AFTER INSERTION. THIS LED TO THE REMOVAL AND INSERTION OF A NEW DEVICE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2636048 INTROCAN SAFETY ® 2 CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS FOZ B BRAUN MELSUNGEN AG

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown