BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDALLION SYRINGE

    MDR report key: 3101608 · Received May 3, 2013

    Report

    Report Number
    1721504-2013-00097
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    April 8, 2013
    Report Date
    April 8, 2013
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    FMF
    PMA / PMN Number
    K875196
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL: THE SUSPECT DEVICE WAS NOT RETURNED FOR EVAL. TWO UNUSED SYRINGES FROM THE SAME LOT WERE RETURNED BY THE USER. THE USER DID NOT SPECIFY IF THIS WAS THE INITIAL USE OF THE DEVICE. A REVIEW OF THE DEVICE HISTORY RECORDS DID NOT REVEAL ANY EXCEPTION DOCUMENTS. THE COMPLAINT DATABASE WAS REVIEWED AND FOUND NO SIMILAR COMPLAINTS FOR THIS LOT NUMBER. THE RETURNED UNUSED SYRINGES WERE VISUALLY INSPECTED AND PERFORMANCE TESTED BY ATTACHING EACH SYRINGE TO A MATING FEMALE COMPONENT. NO DEFECTS WERE FOUND. THE COMPLAINT COULD NOT BE CONFIRMED. MERIT IS UNABLE TO DETERMINE THE ROOT CAUSE OF THE REPORTED FAILURE WITHOUT THE SUSPECT DEVICE. A F/U REPORT WILL BE SUBMITTED IF MORE INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE USER REPORTED THAT DURING AN ELECTROPHYSIOLOGY PROCEDURE THE LUER ON THE SYRINGE DID NOT PROPERLY CONNECT TO A GUIDING CATHETER. AS A RESULT AIR WAS SEEN IN THE SYRINGE PRIOR TO INJECTION. THE SYRINGE WAS THEN EXCHANGED FOR A NEW SYRINGE. NO HARM OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195303 MEDALLION SYRINGE SYRINGE, PISTON FMF MERIT MEDICAL SYSTEMS, INC. H336695

    Patients

    Seq Age Sex Outcome Treatment
    1 CONTRAST MEDIA| GUIDING CATHETER