BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAK-NV¿ MICROPUNCTURE KIT

    MDR report key: 16717136 · Received April 11, 2023

    Report

    Report Number
    3011642792-2023-00026
    Event Type
    Injury
    Date Received
    April 11, 2023
    Date of Event
    April 4, 2023
    Report Date
    April 4, 2023
    Manufacturer
    MERIT MEDICAL SYSTEMS MEXICO
    Product Code
    GCB
    UDI-DI
    00884450013564
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUSPECT DEVICE IS EXPECTED TO RETURN FOR EVALUATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    THE SUSPECT DEVICE WAS RETURNED FOR EVALUATION. THE COMPLAINT WAS CONFIRMED; HOWEVER, THE ROOT CAUSE COULD NOT BE DETERMINED. 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.

    Description of Event or Problem · 0

    THE ACCOUNT ALLEGES THAT POST NEPHROSTOMY TUBE PLACEMENT PROCEDURE, THE TIP OF THE ACCESS GUIDEWIRE WAS MISSING. THE PHYSICIAN WAS UNSUCCESSFUL IN RETRIEVING THE FOREIGN BODY FROM THE PATIENT. THE PATIENT WAS TRANSFERRED TO THE OPERATING ROOM FOR SURGICAL INTERVENTION RESULTING IN THE SUCCESSFUL REMOVAL OF THE FOREIGN BODY. NO ADDITIONAL PATIENT CONSEQUENCES TO REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380524 MAK-NV¿ MICROPUNCTURE KIT NEEDLE, CATHETER GCB MERIT MEDICAL SYSTEMS MEXICO I2572479 00884450013564

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| H MICROPUNCTURE CATHETER| VASCULAR ACCESS NEEDLE