BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERFEKTUM MATCH NUMBERED GLASS SYRINGES

    MDR report key: 3032892 · Received March 29, 2013

    Report

    Report Number
    1213649-2013-00012
    Event Type
    Malfunction
    Date Received
    March 29, 2013
    Date of Event
    January 23, 2013
    Report Date
    January 23, 2013
    Manufacturer
    CADENCE INC.
    Product Code
    FMF
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6) 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) 2013, THE CUSTOMER REPORTED THE GLASS SYRINGE WAS FOUND BROKEN WHEN THE BOX WAS OPENED AND THE METAL LOCK TIP WAS DETACHED. THERE WAS NO PATIENT EXPOSURE AND NO INJURY TO THE USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    129769 PERFEKTUM MATCH NUMBERED GLASS SYRINGES SYRINGE FMF CADENCE INC. 5147 78801-01

    Patients

    Seq Age Sex Outcome Treatment
    1 Other