BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MERIT MINI ACCESS KIT

    MDR report key: 7837401 · Received August 31, 2018

    Report

    Report Number
    3011642792-2018-00016
    Event Type
    Injury
    Date Received
    August 31, 2018
    Date of Event
    August 23, 2018
    Report Date
    August 23, 2018
    Manufacturer
    MERIT MEDICAL SYSTEMS MEXICO
    Product Code
    DRE
    PMA / PMN Number
    K031691
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUSPECT DEVICE IS NOT EXPECTED TO RETURN. A REVIEW OF THE DEVICE HISTORY AND COMPLAINT DATABASE COULD NOT BE PERFORMED SINCE THE LOT NUMBER WAS NOT PROVIDED.

    Description of Event or Problem · 1

    THE ACCOUNT ALLEGES THAT DURING A PERMANENT DIALYSIS CATHETER PLACEMENT PROCEDURE, THE PHYSICIAN IDENTIFIED A DETACHED WIRE TIP WITHIN THE PATIENT'S SUPERIOR VENA CAVA FROM AN EARLIER TEMPORARY DIALYSIS CATHETER PLACEMENT PROCEDURE. THE PHYSICIAN STATES THAT THE WIRE TIP WAS SUCCESSFULLY REMOVED FROM THE PATIENT VIA VASCULAR SNARE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679802 MERIT MINI ACCESS KIT ACCESS KIT DRE MERIT MEDICAL SYSTEMS MEXICO

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R