BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTROCAN SAFETY® 3

    MDR report key: 23531841 · Received November 12, 2025

    Report

    Report Number
    9610825-2025-00656
    Event Type
    Malfunction
    Date Received
    November 12, 2025
    Date of Event
    September 1, 2025
    Report Date
    December 3, 2025
    Manufacturer
    B BRAUN MELSUNGEN AG
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 INVESTIGATION IS ONGOING AT THIS TIME. A FOLLOW- UP WILL BE SUBMITTED WHEN THE INVESTIGATION RESULTS BECOME AVAILABLE. 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.

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). COMPLAINT ANALYSIS: THE SITUATION DESCRIBED AFTER THE CT CONTRAST INJECTION, UPON DISCONNECTION, THE CANNULA WAS BLEEDING OUT, THE INTERNAL VALVE WAS NOT WORKING. EVIDENCE AT DISPOSAL: NO SAMPLE RETURNED BUT RECEIVED A PICTURE SHOWING TWO PEEL PACKAGING. FIRST PEEL PACK FOR ARTICLE INTROCAN SAFETY 3 PUR 20G 1.1X25MM-EU / BATCH NUMBER: 24L11G8372 / ARTICLE NUMBER: 4251129-01. SECOND PEEL PACK SHOWS ARTICLE INTROCAN SAFETY 3 PUR 20G 1.1X25MM-EU / BATCH NUMBER: 24K08G8375 / ARTICLE NUMBER: 4251129-01. NO PICTURE OF PRODUCTS. DEVICE HISTORY RECORD (DHR): REVIEWED THE DEVICE HISTORY RECORD FOR BATCH NUMBER 24L11G8372 AND 24K08G8375 AND THERE WERE NO DEFECT ENCOUNTERED DURING IN PROCESS AND FINAL CONTROL PRODUCT INSPECTION. REVIEWED ASSEMBLY PROCESS: THIS PRODUCT IS ASSEMBLED ON AUTOMATIC ASSEMBLY MACHINES EQUIPPED WITH 100% VISION INSPECTION SYSTEM AND TEST STATIONS. ALONG THE MACHINES, THERE IS VALVE LEAKAGE TEST STATION. THIS TEST SPECIFICALLY ASSESSES THE VALVE'S CAPABILITY TO RETAIN THE PRESSURE BY APPLYING A CONTROLLED PRESSURE AND MONITORING FOR ANY LEAKAGE OR PRESSURE DIFFERENTIAL. ANY UNIT FAILING TO MEET THE STRINGENT CRITERIA OF THIS VALVE LEAKAGE TEST IS AUTOMATICALLY DETECTED AND WILL BE REJECTED AT THE UNLOAD REJECT PARTS STATION, PREVENTING ITS PROGRESSION TO SUBSEQUENT MANUFACTURING STAGES. REVIEWED THE MANUFACTURING PROCESS CARDS FOR THE RELATED MACHINES FOR BATCH 24L11G8372 AND 24K08G8375, NO ABNORMALITY OBSERVED. CONCLUSION: THIS COMPLAINT IS CONCLUDED AS NOT CONFIRMED AS NO ABNORMALITY WAS OBSERVED IN THE PICTURE PROVIDED. NEVERTHELESS, A CAPA HAS BEEN INITIATED FOR FURTHER INVESTIGATION ON THE LEAKAGE REPORTED. 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.

    Description of Event or Problem · 0

    ACCORDING TO THE EVENT DESCRIPTION: "AFTER THE CT CONTRAST INJECTION, UPON DISCONNECTION, THE CANNULA WAS BLEEDING OUT, THE INTERNAL VALVE WAS NOT WORKING (DETACHED DURING THE INJECTION?"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93030 INTROCAN SAFETY® 3 CATHETER,INTRAVASCULAR FOZ B BRAUN MELSUNGEN AG 24L11G8372

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown