BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORONARY CONTROL SYRINGE

    MDR report key: 3901581 · Received May 7, 2014

    Report

    Report Number
    1721504-2014-00095
    Event Type
    Malfunction
    Date Received
    May 7, 2014
    Date of Event
    March 31, 2014
    Report Date
    April 14, 2014
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    FMF
    PMA / PMN Number
    K875196
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: ONE USED SYRINGE WAS RETURNED FOR EVALUATION. THE DEVICE HISTORY RECORD AND COMPLAINT DATABASE COULD NOT BE REVIEWED AS THE USER DID NOT PROVIDE A LOT NUMBER. UPON EXAMINATION THE SILICONE LUBRICANT APPEARS TO HAVE BEEN DEPLETED. MERIT IS UNABLE TO DETERMINE ROOT CAUSE.

    Description of Event or Problem · 1

    THE USER REPORTED THAT THE SYRINGE TIP SEPARATED FROM THE PLUNGER DURING A CARDIAC PROCEDURE. THE PHYSICIAN REPLACED THE SYRINGE AND COMPLETED THE PROCEDURE. NO HARM OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    276097 CORONARY CONTROL SYRINGE SYRINGE, PISTON FMF MERIT MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1