BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARROW

    MDR report key: 9395328 · Received December 2, 2019

    Report

    Report Number
    9395328
    Event Type
    Injury
    Date Received
    December 2, 2019
    Date of Event
    November 15, 2019
    Report Date
    November 20, 2019
    Manufacturer
    ARROW INTERNATIONAL, INC. (SUBSIDIARY OF TELEFLEX, INC.)
    Product Code
    DYB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN WAS INSERTING A RIGHT CENTRAL LINE USING THE TWO LUMEN CENTRAL VENOUS ACCESS KIT FROM ARROW'S MAC PRODUCT LINE. WHILE INSERTING THE GUIDEWIRE, RESISTANCE WAS MET AND IT WAS DIFFICULT TO REMOVE. HE REMOVED THE GUIDEWIRE AND ENDED UP USING A DIFFERENT SIZE GUIDEWIRE. AFTER THE PROCEDURE, ON X-RAY, THERE WAS AN APPARENT RETAINED PORTION OF THE GUIDEWIRE. THIS PORTION WAS REMOVED DURING A PREPLANNED SURGICAL PROCEDURE THE NEXT DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1191195 ARROW INTRODUCER, CATHETER DYB ARROW INTERNATIONAL, INC. (SUBSIDIARY OF TELEFLEX, INC.)

    Patients

    Seq Age Sex Outcome Treatment
    1 26645 DA Other| R