BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERIT MAK MINI ACCESS KIT

    MDR report key: 3842584 · Received May 26, 2014

    Report

    Report Number
    3842584
    Event Type
    Malfunction
    Date Received
    May 26, 2014
    Date of Event
    May 22, 2014
    Report Date
    May 26, 2014
    Manufacturer
    MERIT MEDICAL SYSTEMS
    Product Code
    DRE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    LA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN ATTEMPTED ACCESS TO RIGHT FEMORAL VEIN WITH MINI-STICK ACCESS KIT. THE GUIDE WIRE BROKE OFF DURING USE AND THE MD HAD TO RETRIEVE IT FROM THE PATIENT'S BLOOD VESSEL. NO HARM OCCURRED TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309908 MERIT MAK MINI ACCESS KIT DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION DRE MERIT MEDICAL SYSTEMS MAK501N / 5F 10CM H605337

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR MINI ACCESS KIT WHICH CONTAINS: NITINOL GUIDE WIRE| INTRODUCER NEEDLE, AND CO-AXIAL INTRODUCER.