BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO-MATE TUBERCULIN GLASS SYRINGE

    MDR report key: 3193258 · Received June 25, 2013

    Report

    Report Number
    1213649-2013-00022
    Event Type
    Malfunction
    Date Received
    June 25, 2013
    Date of Event
    May 22, 2013
    Report Date
    June 21, 2013
    Manufacturer
    CADENCE INC.
    Product Code
    FMF
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2013, IT WAS REPORTED 2 GLASS SYRINGES PART NUMBER 5208 WERE FOUND TO BE BROKEN WHEN TAKEN OUT OF THE BOX AND PRIOR TO FIRST USE. THERE WAS NO PATIENT EXPOSURE AND NO INJURY TO THE USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288695 MICRO-MATE TUBERCULIN GLASS SYRINGE SYRINGE FMF CADENCE INC. 5208 82350/1

    Patients

    Seq Age Sex Outcome Treatment
    1 Other