BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DYNAREX EPIRITE SYRINGE

    MDR report key: 9418977 · Received December 5, 2019

    Report

    Report Number
    2431014-2019-00002
    Event Type
    Malfunction
    Date Received
    December 5, 2019
    Report Date
    December 5, 2019
    Manufacturer
    DYNAREX CORPORATION
    Product Code
    FMF
    UDI-DI
    00616784698526
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    REFERENCE REPORT NUMBER MW5087168 FOR INCOMPLETE SYRINGE GRADUATIONS. NOTE: AN ADVERSE EVENT DID NOT OCCUR. A PHYSICIAN WAS REPORTING THE ISSUE OF INCOMPLETE GRADUATION MARKINGS ON THE SYRINGE FOR YOUNG CHILDREN. DYNAREX PROVIDES A SYRINGE THAT IS A COMPONENT IN A KIT, AND MAKES NO REFERENCE OR RECOMMENDATIONS REGARDING DOSAGE. IT IS THE RESPONSIBILITY OF THE KIT MANUFACTURER TO DETERMINE SYRINGE SUITABILITY AND APPROPRIATENESS FOR USE AS PART OF THE FINISHED COMBINATION KIT. DYNAREX DID NOT INITIATE THE IFU FOR THE DRUG IN THE PACKAGE INSERT AND CANNOT ACCEPT RESPONSIBILITY FOR PRODUCT INCOMPATIBILITY OR SYRINGE GRADUATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1215287 DYNAREX EPIRITE SYRINGE PISTON SYRINGE FMF DYNAREX CORPORATION 6985 UNKNOWN 00616784698526

    Patients

    Seq Age Sex Outcome Treatment
    1