BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARACENTESIS PROCEDURE TRAY

    MDR report key: 24583327 · Received March 12, 2026

    Report

    Report Number
    1721504-2026-00920
    Event Type
    Malfunction
    Date Received
    March 12, 2026
    Date of Event
    October 3, 2025
    Report Date
    March 12, 2026
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC
    Product Code
    PYC
    UDI-DI
    00884450038710
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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 REVIEW OF THE DEVICE HISTORY AND COMPLAINT DATABASE COULD NOT BE PERFORMED SINCE THE LOT NUMBER WAS NOT PROVIDED. NONCONFORMANCES OF THIS NATURE ARE MONITORED BY THE OPERATION TEAM. THIS COMPLAINT WILL BE USED TO TREND FOR SIMILAR COMPLAINTS.

    Description of Event or Problem · 0

    THE ACCOUNT ALLEGES THAT DURING A THERAPEUTIC PARACENTESIS PROCEDURE, THE PHYSICIAN REPORTED THAT THE CATHETER WAS NOT DRAINING. UPON REMOVAL OF THE DEVICE, IT WAS NOTED THAT THE CATHETER TIP WAS MISSING. ULTRASOUND IMAGING CONFIRMED THAT THE CATHETER TIP WAS RETAINED IN THE SUBCUTANEOUS TISSUE OF THE RIGHT LOWER QUADRANT OF THE ABDOMEN. SURGICAL CONSULTATION WAS OBTAINED AND REMOVAL OF THE RETAINED FRAGMENT WAS SCHEDULED. THE DEVICE AND PACKAGING WERE NOT RETAINED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    638854 PARACENTESIS PROCEDURE TRAY CLOSED-WOUND DRAIN PYC MERIT MEDICAL SYSTEMS, INC 00884450038710

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention