BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE-STEP CENTESIS CATHETER

    MDR report key: 1993601 · Received January 6, 2011

    Report

    Report Number
    1721504-2011-00001
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    December 10, 2010
    Report Date
    December 10, 2010
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    GBX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL: THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR EVAL/INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVAL HAS BEEN COMPLETED. EVAL CONCLUSION: A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVAL HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CATHETER SHEATH SEPARATED FROM THE HUB DURING THE REMOVAL OF THE DEVICE UPON COMPLETION OF A THORACENTESIS PROCEDURE. THE CATHETER REMAINED INSIDE THE PT. PT WAS TAKEN TO SURGERY TO REMOVE THE CATHETER. THE DEVICE HAS BEEN TURNED OVER TO THE RISK MANAGEMENT DEPARTMENT AND WILL NOT BE RETURNED FOR EVAL. NO ADDITIONAL INFO HAS BEEN MADE AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE-STEP CENTESIS CATHETER CATHETER, IRRIGATION GBX MERIT MEDICAL SYSTEMS, INC. H152483

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention