BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIFIX

    MDR report key: 3111460 · Received April 24, 2013

    Report

    Report Number
    2523676-2013-00101
    Event Type
    Malfunction
    Date Received
    April 24, 2013
    Date of Event
    April 3, 2013
    Report Date
    April 5, 2013
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY ((B)(6)): DURING THE CVC WASHING, THE PISTON GASKET OF THE SYRINGE CAUSED THE LEAKAGE OF NACL SOLUTION DIRECTLY TO THE OPERATOR. IN CASE OF ASPIRATION OF BIOLOGICAL FLUIDS, IT WOULD HAVE CAUSED A CONTAMINATION OF THE OPERATOR. REF MFR REPORT: 9610825-2013-00101.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    177785 OMNIFIX HYPODERMIC SYRINGE FMF B. BRAUN MELSUNGEN AG NA 3A21048

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other