BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFE-T-CENTESIS

    MDR report key: 11669136 · Received April 15, 2021

    Report

    Report Number
    11669136
    Event Type
    Malfunction
    Date Received
    April 15, 2021
    Date of Event
    August 21, 2019
    Report Date
    September 11, 2019
    Manufacturer
    CAREFUSION 2200, INC
    Product Code
    GCB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE PATIENT HAD A THORACENTESIS PERFORMED DURING WHICH TIME THE SAFE-T-CENTESIS KIT TUBING WAS ATTACHED TO THE CATHETER. PLEURAL FLUID WAS EASILY ASPIRATED INTO A SYRINGE FROM THE CATHETER BUT WAS UNABLE TO BE ASPIRATED THROUGH THE TUBING INTO THE COLLECTION BAG. A NEW KIT WAS THEN OPENED, AND THE PLEURAL FLUID WAS ABLE TO BE ASPIRATED INTO THE TUBING INTO THE COLLECTION BAG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572070 SAFE-T-CENTESIS THORACENTESIS TRAY GCB CAREFUSION 2200, INC 0001308906

    Patients

    Seq Age Sex Outcome Treatment
    1 17885 DA