BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3 LUMEN CATHETER

    MDR report key: 6696565 · Received July 7, 2017

    Report

    Report Number
    MW5070845
    Event Type
    Malfunction
    Date Received
    July 7, 2017
    Date of Event
    January 25, 2016
    Report Date
    March 8, 2016
    Manufacturer
    CENTURION 1-800-248-5068
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    RIGHT IJ 7 FR TRIPLE LUMEN CENTRAL LINE INSERTED (B)(6) 2016. PATIENT WITH INADEQUATE PERIPHERAL ACCESS, IV MEDS/FLUIDS INFUSED SAFETY ONLY THROUGH CVC, NEED FOR MULTIPLE IV PORTS. ON (B)(6) 2016 DRESSING NOTED TO BE WET AFTER FLUSHING TO DRAW LABS, WHEN DRESSING PULLED BACK AND SALINE PUSHED IT SQUIRTED STRAIGHT OUT OF A CRACK/SPLIT IN THE CATHETER APPROX. 1MM FROM THE PROXIMAL HUB. BOTH BLUE AND BROWN PORTS SQUIRT OUT WHEN FLUSHED, WHITE PORT DOES NOT. BLUE AND BROWN PORTS CLAMPED. PATIENT WITH CEREBRAL PALSY BROUGHT TO ER FOR PEA. PATIENT HAD POOR PROGNOSIS AND EXPIRED - UNRELATED TO CENTRAL LINE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    473620 3 LUMEN CATHETER 3 LUMEN CATHETER DYB CENTURION 1-800-248-5068 7F

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR