BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SKATER CENTESIS CATHETER

    MDR report key: 3970026 · Received July 25, 2014

    Report

    Report Number
    3970026
    Event Type
    Malfunction
    Date Received
    July 25, 2014
    Date of Event
    April 11, 2014
    Report Date
    July 25, 2014
    Manufacturer
    ARGON MEDICAL DEVICES, INC.
    Product Code
    GBQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN AND ULTRASOUND (US) TECH WERE PERFORMING A THORACENTESIS PROCEDURE WHEN THE HUB OF THE CATHETER BROKE OFF. THE PHYSICIAN REMOVED CATHETER AND PLACED A LARGER ONE AND CONTINUED TO DRAIN THE FLUID. AFTER THE PROCEDURE, A CHEST X-RAY REVEALED A PNEUMOTHORAX AND THE PATIENT WAS MONITORED AND ADDITIONAL CHEST X-RAY WAS TAKEN. THE PNEUMOTHORAX REDUCED IN SIZE AND A CHEST TUBE WAS NOT NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    435600 SKATER CENTESIS CATHETER CATHETER, CONTINUOUS IRRIGATION GBQ ARGON MEDICAL DEVICES, INC. * 1062271

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR