BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCARDIOCENTESIS KIT.STERILE

    MDR report key: 13778733 · Received March 16, 2022

    Report

    Report Number
    1125782-2022-00002
    Event Type
    Injury
    Date Received
    March 16, 2022
    Date of Event
    March 2, 2022
    Report Date
    March 8, 2022
    Manufacturer
    MERIT MEDICAL RICHMOND
    Product Code
    PXU
    UDI-DI
    00884450486115
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUSPECT DEVICE WAS NOT RETURNED FOR EVALUATION. THE COMPLAINT COULD NOT BE CONFIRMED. 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.

    Additional Manufacturer Narrative · 0

    THE SUSPECT DEVICE IS NOT EXPECTED TO RETURN FOR EVALUATION. A FOLLOW UP WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 0

    THE ACCOUNT ALLEGES THAT THE DEVICE DIDN'T ADEQUATELY DRAIN THE FLUID FROM THE PATIENT'S PAERICARDIAL SACK DURING THE PROCEDURE. THE DEVICE WAS REPLACED WITH ANOTHER AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1246744 PERCARDIOCENTESIS KIT.STERILE CUSTOM KIT PXU MERIT MEDICAL RICHMOND T2031818 00884450486115

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| L