BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VALVED ONE-STEP CENTESIS CATHETER

    MDR report key: 3030848 · Received March 28, 2013

    Report

    Report Number
    1721504-2013-00065
    Event Type
    Malfunction
    Date Received
    March 28, 2013
    Date of Event
    February 28, 2013
    Report Date
    February 28, 2013
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    GBX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR EVALUATION. THE USER INDICATED THE USED DEVICE WAS DISCARDED AT THE FACILITY POST PROCEDURE. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE USER REPORTED THAT DURING A THORACENTESIS PROCEDURE, THEY WERE UNABLE TO DRAW BACK TO PULL FLUID FROM THE PT. THEY ALSO NOTICED AIR BEING INTRODUCED INTO THE PLEURAL SPACE CAUSING A SMALL PNEUMOTHORAX WHEN THE NEEDLE IS WITHDRAWN FROM THE VALVE. THE PNEUMOTHORAX DID NOT REQUIRE TREATMENT. THE USER INDICATED THE PNEUMOTHORAX MAY HAVE BEEN CAUSED BY ANOTHER DEVICE/COMPONENT DURING THE PROCEDURE. NO HARM OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127503 VALVED ONE-STEP CENTESIS CATHETER CATHETER, IRRIGATION GBX MERIT MEDICAL SYSTEMS, INC. H429892

    Patients

    Seq Age Sex Outcome Treatment
    1 DRAINAGE TUBING