BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERFECTUM TUBERCULIN GLASS SYRINGE

    MDR report key: 3038034 · Received April 1, 2013

    Report

    Report Number
    1213649-2013-00017
    Event Type
    Malfunction
    Date Received
    April 1, 2013
    Date of Event
    September 12, 2011
    Report Date
    September 12, 2011
    Manufacturer
    CADENCE INC.
    Product Code
    FMF
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ON (B)(6) 2011, IT WAS REPORTED THAT THE O-RING ON THE SYRINGE PLUNGER BROKE. NO INFO WAS AVAILABLE ON WHETHER THIS OCCURRED DURING A PROCEDURE OR IF THE PROCEDURE WAS COMPLETED. IF ADD'L INFO IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    132371 PERFECTUM TUBERCULIN GLASS SYRINGE SYRINGE FMF CADENCE INC. 5212 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other