BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUHRMAN PLEURAL PNEUMOPERICARDIAL DRAINAGE SET

    MDR report key: 3937361 · Received June 11, 2014

    Report

    Report Number
    3937361
    Event Type
    Malfunction
    Date Received
    June 11, 2014
    Date of Event
    June 2, 2014
    Report Date
    June 11, 2014
    Manufacturer
    COOK MEDICAL INC
    Product Code
    DQO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD PIGTAIL CHEST TUBE TO SUCTION WITH INTERMITTENT LEAK. RN NOTICED INCREASED BUBBLING AND CAME TO OFFICE TO TELL NPS (NURSE PRACTITIONERS). NPS TO ROOM TO ASSESS. TOOK DOWN DRESSING AND FOUND TUBE WAS COMPLETELY BROKEN PROXIMAL TO THE HUB. IT WAS RECOMMENDED BY PHYSICIANS TO PULL THE TUBE. THE CHEST TUBE WAS PULLED. WHEN HEMOSTAT WAS ATTACHED TO TUBE THE TUBE CONTINUES TO CHIP OFF AND BREAK INTO TINY PIECES. NO DIFFICULTY INSERTING THE DEVICE AND NO VISUAL INDICATION THAT THE DEVICE WAS FAULTY PRIOR TO INSERTION. PACKAGING INTACT PRIOR TO USE. DEVICE WAS IN THE FACILITY'S DEPARTMENT FOR APPROXIMATELY 10 MONTHS PRIOR TO USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343655 FUHRMAN PLEURAL PNEUMOPERICARDIAL DRAINAGE SET CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO COOK MEDICAL INC C-PPE-850-IMH 4456836

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR