BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRESSURE CONTROL GLASS SYRINGE

    MDR report key: 3027277 · Received March 22, 2013

    Report

    Report Number
    1213649-2013-00002
    Event Type
    Malfunction
    Date Received
    March 22, 2013
    Date of Event
    January 17, 2012
    Report Date
    January 17, 2012
    Manufacturer
    CADENCE INC.
    Product Code
    FMF
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    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 ON-COMPLIANT DURING AN INTERNAL REVIEW OF OUR COMPLAINT FILES.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE PHYSICIAN REPORTED THE GLASS SYRINGE WAS FOUND BROKEN WHEN THE BOX WAS OPENED. THERE WAS NO PATIENT EXPOSURE AND NO INJURY TO THE USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    120841 PRESSURE CONTROL GLASS SYRINGE SYRINGE FMF CADENCE INC. 5338 79335-01

    Patients

    Seq Age Sex Outcome Treatment
    1 Other