BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERICARDIOCENTESIS KIT

    MDR report key: 21694165 · Received March 25, 2025

    Report

    Report Number
    1125782-2025-00003
    Event Type
    Injury
    Date Received
    March 25, 2025
    Date of Event
    March 18, 2025
    Report Date
    March 25, 2025
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    PXU
    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 CATHETER SHAFT HAD SEPARATED FROM THE STRAIN RELIEF, BUT THE CATHETER TIP WAS FOUND TO BE INTACT ON THE CATHETER BODY. THE SEPARATION OCCURRED TO MISALIGNMENT OF THE CATHETER PARTS DURING MOLDING. 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 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 CATHETER DETACHED FROM THE JUNCTION WITHIN THE PATIENT. THE TIP WAS RETRIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1100848 PERICARDIOCENTESIS KIT FLUID DRAINAGE TRAY PXU MERIT MEDICAL SYSTEMS, INC. T3088168

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention