BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAFETY CENTESIS CATHETER TRAY 8R

    MDR report key: 21548655 · Received March 7, 2025

    Report

    Report Number
    MW5167386
    Event Type
    Injury
    Date Received
    March 7, 2025
    Date of Event
    February 20, 2025
    Report Date
    March 3, 2025
    Manufacturer
    CARDINAL HEALTH 200, LLC.
    Product Code
    PYC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    SPRING FAILED TO ACTIVATE AND SEAL CATHETER CHAMBER WITH SMALL BALL BEARING CAUSING AIR TO BE REINTRODUCED INTO THORACIC CAVITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2104436 SAFETY CENTESIS CATHETER TRAY 8R PARACENTESIS TRAY PYC CARDINAL HEALTH 200, LLC. CAT.30-CE1SFA 514269

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Male Required Intervention