BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERIT MAK KITS

    MDR report key: 3101939 · Received May 3, 2013

    Report

    Report Number
    1721504-2013-00095
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    April 9, 2013
    Report Date
    April 9, 2013
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    DRE
    PMA / PMN Number
    K031691
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE SUSPECT DEVICE IS NOT EXPECTED TO BE RETURNED FOR EVALUATION. THE DEVICE HISTORY RECORD AND COMPLAINT DATABASE COULD NOT BE REVIEWED AS THE USER DID NOT PROVIDE A LOT NUMBER. PER THE INSTRUCTIONS FOR USE THE DEVICE IS INTENDED FOR PERCUTANEOUS PLACEMENT OF A 0.035" OR 0.038" GUIDE WIRE INTO THE VASCULAR SYSTEM. MERIT IS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED FAILURE WITHOUT THE SUSPECT DEVICE. A FOLLOW-UP REPORT WILL BE SUBMITTED IF MORE INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE USER REPORTED THAT DURING A FISTULOGRAM PROCEDURE THE BUG OF THE MINI ACCESS KIT DETACHED FROM THE BODY OF THE DEVICE. THE USER WAS MANUALLY INJECTING CONTRAST WITH A SYRINGE THROUGH A FLOW SWITCH THAT HAD BEEN ATTACHED TO THE MINI ACCESS DEVICE. WHILE INJECTING CONTRAST AND MANIPULATING THE ASSEMBLY THE DEVICE KINKED AND THE HUB DETACHED. THE USER DID NOT PROVIDE A LOT NUMBER. NO HARM OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194508 MERIT MAK KITS DILATOR, VESSEL, FOR .. CATHETERIZATION DRE MERIT MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 FLOW SWITCH| SYRINGE| CONTRAST MEDIA