BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERFEKTUM TUBERCULIN GLASS SYRINGES

    MDR report key: 3038014 · Received April 1, 2013

    Report

    Report Number
    1213649-2013-00019
    Event Type
    Malfunction
    Date Received
    April 1, 2013
    Date of Event
    November 4, 2011
    Report Date
    November 4, 2011
    Manufacturer
    CADENCE INC.
    Product Code
    FMF
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CADENCE ACKNOWLEDGES THIS REPORT DOES NOT MEET THE THIRTY DAY REPORTING REQUIREMENT. THIS WAS UNINTENTIONAL. THIS REPORT IS BEING FILED AFTER IT WAS IDENTIFIED AS NON-COMPLIANT DURING INTERNAL REVIEW OF OUR COMPLAINT FILES.

    Description of Event or Problem · 1

    PRIOR TO USE ON (B)(6) 2011, IT WAS REPORTED THE SYRINGE GRADUATIONS ON THE BARREL SAYS .5 AND SHOULD BE .05.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    132595 PERFEKTUM TUBERCULIN GLASS SYRINGES SYRINGES FMF CADENCE INC. 5200 80069-03

    Patients

    Seq Age Sex Outcome Treatment
    1 Other