BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW MAC TWO-LUMEN CENTRAL VENOUS ACCESS KIT WITH ARROWG+AR

    MDR report key: 3937338 · Received July 15, 2014

    Report

    Report Number
    3937338
    Event Type
    Malfunction
    Date Received
    July 15, 2014
    Date of Event
    June 23, 2014
    Report Date
    July 15, 2014
    Manufacturer
    TELEFLEX INC.
    Product Code
    LJS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A TRAUMA PATIENT REQUIRED A VENOUS ACCESS. THE DOCTOR TRIED TO FEED THE SPRING-WIRE INTO THE LINE. THE WIRE WOULD NOT ADVANCE THROUGH THE WHITE HUB. THE WIRE KINKED AND THE LINE WAS NOT USABLE BECAUSE OF THIS. ANOTHER KIT WAS OBTAINED AND NO FURTHER PROBLEMS WERE ENCOUNTERED WITH THE SECOND KIT.THIS FACILITY HAD A SIMILAR PROBLEM WITH THIS DEVICE TYPE A FEW MONTHS AGO. PRODUCT HAS BEEN RETURNED TO THE MANUFACTURER. THE CAUSE OF THE PROBLEM IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412172 ARROW MAC TWO-LUMEN CENTRAL VENOUS ACCESS KIT WITH ARROWG+AR INTRODUCER, CATHETER LJS TELEFLEX INC. * 23F14A0529 012314

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR