BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MERIT MAK¿

    MDR report key: 18044407 · Received October 31, 2023

    Report

    Report Number
    3011642792-2023-00071
    Event Type
    Injury
    Date Received
    October 31, 2023
    Date of Event
    October 24, 2023
    Report Date
    October 25, 2023
    Manufacturer
    MERIT MEDICAL SYSTEMS MEXICO
    Product Code
    GCB
    UDI-DI
    00884450012574
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUSPECT DEVICE WAS RETURNED FOR EVALUATION. THE COMPLAINT WAS CONFIRMED. THE MOST PROBABLE CAUSE OF THIS OCCURRENCE IS FORCES IMPOSED UPON THE DEVICE WHEN TORTUOUS ANATOMY WAS ENCOUNTERED IN CLINIC. A SEARCH OF THE COMPLAINT DATABASE WAS PERFORMED AND NO SIMILAR COMPLAINTS FOR THIS LOT NUMBER WERE FOUND. THE DEVICE HISTORY RECORD WAS REVIEWED, AND NO EXCEPTION DOCUMENTS WERE FOUND.

    Additional Manufacturer Narrative · 0

    THE SUSPECT DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. A FOLLOW UP WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 0

    THE ACCOUNT ALLEGES THAT DURING A PROCEDURE FOR UPPER ARM CENTRAL VENOUS ACCESS, THE TIP OF THE GUIDEWIRE DETACHED WITHIN THE VESSEL. THE DETACHED TIP WAS SUCCESSFULLY RETRIEVED OUT FROM THE PATIENT. NO OTHER PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2199413 MERIT MAK¿ NEEDLE, CATHETER GCB MERIT MEDICAL SYSTEMS MEXICO I2603366 00884450012574

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention