BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIFIX®

    MDR report key: 24531135 · Received March 6, 2026

    Report

    Report Number
    9610825-2026-00094
    Event Type
    Malfunction
    Date Received
    March 6, 2026
    Date of Event
    February 11, 2026
    Report Date
    March 6, 2026
    Manufacturer
    B BRAUN MELSUNGEN AG
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN INTERNAL REPORT NUMBER (B)(4). 1 PICTURE OF AN OMNIFIX 10 ML LL. WAS RECEIVRED. THE FOLLOWING INVESTIGATION WAS CONDUCTED: VISUAL INSPECTION: THE PICTURED SAMPLE WAS TAKEN TO A VISUAL INSPECTION FOR DAMAGES. THE SYRINGE SHOWN HAS A BROKEN THUMB PRESSURE PLATE. SUMMARY AND ASSESSMENT: THE BATCH HISTORY REVIEW WAS CONDUCTED, AND NO DAMAGE OR ABNORMALITIES WERE IDENTIFIED. BASED ON THE CURRENT AVAILABLE INVESTIGATION RESULTS, THE PICTURED SAMPLE IS NOT WITHIN SPECIFICATION. THE DEFECT WAS LIKELY CAUSED DURING PACKAGING. THE SYRINGE MAY HAVE JAMMED IN THE GUIDE RAILS OR BEEN DAMAGED BY ANOTHER JAMMED SYRINGE. THEREFORE, THE DEFECT IS CONSIDERED AS 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: UDI NUMBER (B)(4). PREMARKET SUBMISSION # K193101.

    Description of Event or Problem · 0

    ACCORDING TO THE COMPLAINANT: "A 19 ML OUERLOCK SYRINGE BROKE WHEN TRYING TO INJECT CONTRAST THROUGH THE TRANSSEPTAL NEEDLE. CRITICAL SITUATION AS ONE PUNCTURES FROM THE RIGHT ATRIUM TO THE LEFT ATRIUM. THIS HAS HAPPENED BEFORE AND CAN LEAD TO LOSING THE POSITION AS WELL AS THE STERILE GLOVES BEING TORN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350814 OMNIFIX® SYRINGE, PISTON FMF B BRAUN MELSUNGEN AG

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown