BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRESSURE CONTROL GLASS SYRINGE

    MDR report key: 3027276 · Received March 22, 2013

    Report

    Report Number
    1213649-2013-00003
    Event Type
    Malfunction
    Date Received
    March 22, 2013
    Date of Event
    July 16, 2012
    Report Date
    July 17, 2012
    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 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 HOSPITAL REPORTED FINDING THE SYRINGE BROKEN WHEN THE BOX WAS OPENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    119904 PRESSURE CONTROL GLASS SYRINGE SYRINGE FMF CADENCE INC. 5341 W000203

    Patients

    Seq Age Sex Outcome Treatment
    1 Other