BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAK-NV¿ INTRODUCER SYSTEM

    MDR report key: 17076195 · Received June 6, 2023

    Report

    Report Number
    3011642792-2023-00042
    Event Type
    Injury
    Date Received
    June 6, 2023
    Date of Event
    May 18, 2023
    Report Date
    June 2, 2023
    Manufacturer
    MERIT MEDICAL SYSTEMS MEXICO
    Product Code
    GCB
    UDI-DI
    00884450013588
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUSPECT DEVICE IS NOT EXPECTED TO RETURN FOR EVALUATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    THE SUSPECT MEDICAL DEVICE WAS NOT RETURNED FOR EVALUATION. THE COMPLAINT COULD NOT BE CONFIRMED. THE ROOT CAUSE COULD NOT BE DETERMINED. THE DEVICE HISTORY RECORD WAS REVIEWED, AND NO EXCEPTION DOCUMENTS WERE FOUND. A SEARCH OF THE COMPLAINT DATABASE WAS PERFORMED AND NO SIMILAR COMPLAINTS FOR THIS LOT NUMBER WAS IDENTIFIED. SHOULD THE DEVICE BE RETURNED LATER, THE INVESTIGATION WILL BE REOPENED.

    Additional Manufacturer Narrative · 0

    THE SUSPECT MEDICAL DEVICE WAS NOT RETURNED FOR EVALUATION. THE COMPLAINT COULD NOT BE CONFIRMED. THE ROOT CAUSE COULD NOT BE DETERMINED. THE DEVICE HISTORY RECORD WAS REVIEWED, AND NO EXCEPTION DOCUMENTS WERE FOUND. A SEARCH OF THE COMPLAINT DATABASE WAS PERFORMED AND NO SIMILAR COMPLAINTS FOR THIS LOT NUMBER WAS IDENTIFIED. SHOULD THE DEVICE BE RETURNED LATER, THE INVESTIGATION WILL BE REOPENED.

    Description of Event or Problem · 0

    THE ACCOUNT ALLEGES THAT WHILE PLACING A NEPHROSTOMY TUBE, THE GUIDEWIRE (2CM PIECE) DETACHED WITHIN THE PATIENT ANATOMY. THE PATIENT WAS TRANSFERRED TO THE OPERATING ROOM AND THE FOREIGN BODY WAS SUCCESSFULLY REMOVED. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    587880 MAK-NV¿ INTRODUCER SYSTEM NEEDLE, CATHETER GCB MERIT MEDICAL SYSTEMS MEXICO 00884450013588 I2496078 00884450013588

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention