BEUDAMED
    FDA Adverse Event Other Summary report: N

    DEROYAL

    MDR report key: 2669670 · Received July 10, 2012

    Report

    Report Number
    1060680-2012-00005
    Event Type
    Other
    Date Received
    July 10, 2012
    Date of Event
    May 18, 2012
    Report Date
    June 29, 2012
    Manufacturer
    COEUR LABORATORIES, INC.
    Product Code
    DXT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEROYAL: THE DEFECTIVE SAMPLE HAS NOT BEEN RETURNED TO DEROYAL AT THIS TIME FOR INVESTIGATION. THIS PRODUCT IS SUPPLIED TO OUR COMPANY BY (B)(4).

    Description of Event or Problem · 1

    THE POWER INJECTOR THAT THE END USER USED SPRAYED CONTRAST ALL OVER THE PT, PHYSICIAN, AND STAFF INVOLVED IN THE CASE. THE SYRINGE AT THE TIME WAS FILLED WITH CONTRAST AND SOME BLOOD. THE SYRINGE USED WAS A DEROYAL CATALOG NUMBER: 77-150269, LOT NUMBER: IM079-1112. THE POWER INJECTOR ALSO WAS REPORTED TO BIOMED TO BE LOOKED AT THE SAME DAY. ALL STAFF WERE WEARING PROTECTIVE EQUIPMENT, GLOVES, AND EYE PROTECTION. THERE WAS NO EXPOSURE OF BLOOD/BODY FLUIDS TO ANYONE IN THE ROOM. THE STAFF AND PHYSICIAN INVOLVED IN THE CASE ARE VERY EXPERIENCED WITH THIS PROCEDURE AND EQUIPMENT. THERE WERE NO VISUAL DEFECTS TO ANY PIECE OF EQUIPMENT IN USE PRIOR TO THE EVENT AND NO INDICATIONS THAT THE DEVICE WOULD MALFUNCTION. STAFF REPORTED THAT THIS HAS HAPPENED TWICE BEFORE. NO OTHER INFO FROM THE PREVIOUS EXPERIENCE IS AVAILABLE. THERE WAS NO HARM TO THE PT, STAFF, OR PHYSICIAN IN THIS CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEROYAL POWER INJECTOR SYRINGE DXT COEUR LABORATORIES, INC. 77-150269 IM079-1112

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Other