BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE-STEP CENTESIS CATHETER

    MDR report key: 3848462 · Received May 21, 2014

    Report

    Report Number
    1721504-2014-00107
    Event Type
    Injury
    Date Received
    May 21, 2014
    Date of Event
    April 25, 2014
    Report Date
    April 25, 2014
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    GBX
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL: ONE USED DEVICE RETURNED FOR EVAL. THE EVAL IS IN PROCESS. A F/U REPORT WILL BE SUBMITTED WHEN THE EVAL HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE USER REPORTED THAT DURING A THORACENTESIS, THE NEEDLE OF THE DEVICE COULD NOT BE REMOVED. THE USER WAS ABLE TO GET A LIMITED AMOUNT OF FLUID FOR TESTING, BUT COULD NOT CONTINUE THE PROCEDURE TO DRAIN THE PT'S PLURAL SPACE. THE FACILITY HAS A POLICY OF ONLY GAINING ACCESS FOR THORACENTESIS ONCE. THE PT WILL NEED TO RETURN FOR AN ADD'L PROCEDURE AT A LATER DATE. NO FURTHER HARM OR INJURY TO THE PT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303709 ONE-STEP CENTESIS CATHETER CATHETER, IRRIGATION GBX MERIT MEDICAL SYSTEMS, INC. H580548

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention