BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTROCAN SAFETY® 3

    MDR report key: 22326925 · Received June 25, 2025

    Report

    Report Number
    9610825-2025-00375
    Event Type
    Malfunction
    Date Received
    June 25, 2025
    Report Date
    June 25, 2025
    Manufacturer
    B BRAUN MELSUNGEN AG
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). RECEIVED TOTAL 10 PIECES OF INTROCAN SAFETY 3 PUR 20G 1.1X25MM-EU IN ORIGINAL PACKAGING FROM BATCH 24L11G8374 AND MATERIAL# 4251128-02. ALL RETURNED SAMPLES WERE VISUALLY INSPECTED AND FUNCTIONALLY TESTED AT BMI. RESULTS WERE REPORTED AS PASSED. ASSEMBLY PROCESS CARD WAS REVIEWED. NO ABNORMALITY DURING MANUFACTURING OF THE COMPLAINT BATCH. FINAL CONTROL AND IPQC VISUAL INSPECTION AND FUNCTIONAL TEST RESULTS WERE REVIEWED FOR COMPLAINT BATCH 24L11G8374. ALL RESULTS WERE REPORTED AS PASSED. THEREFORE, THIS COMPLAINT IS CONCLUDED AS NOT CONFIRMED. REVIEW ON FINAL CONTROL AND IPQC INSPECTION RESULTS ESPECIALLY ON FUNCTIONAL TEST ON LEAKAGES FOR COMPLAINT BATCH 24N03G8951 WAS PERFORMED. ALL RESULTS WERE REPORTED AS PASSED. 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: "UNFORTUNATELY I NEED TO REPORT AN ISSUE WITH A SPECIFIC LOT OF IS3 20G. THE NO BLOOD SPILL VALVE DID NOT WORK. THERE WAS NO HARM TO PATIENTS OR STAFF BUT CT (WHO HAVE USED THESE CANNULAS FOR YEARS NOW AND LOVE THEM) HAD 4 CANNULAS ALL OF THE SAME LOT ON THE SAME DAY THAT SPILT BLOOD. I HAVE 5 BOXES OF THIS LOT NUMBER FROM CT THAT THEY DO NOT WANT TO USE, SO THEY ARE IN MY OFFICE. I HAVE ONLY JUST BEEN MADE AWARE OF THIS, SO HAVE NOT PULLED THEM FROM ANY OTHER AREA AT PRESENT. I DO NOT BELIEVE THAT THIS POSES ANY RISK TO PATIENTS BUT IT IS CLEARLY NOT WORKING AS IT SHOULD.".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2290597 INTROCAN SAFETY® 3 CATHETER,INTRAVASCULAR FOZ B BRAUN MELSUNGEN AG 24L11G8374

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown