BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARROW MULTI-LUMEN PI CVC KIT: 3-L 7 FR X 6"

    MDR report key: 9379250 · Received November 26, 2019

    Report

    Report Number
    9680794-2019-00461
    Event Type
    Injury
    Date Received
    November 26, 2019
    Date of Event
    October 6, 2019
    Report Date
    November 5, 2019
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    FOZ
    PMA / PMN Number
    K071538
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    QN# (B)(4). THE MEDWATCH INDICATES A SERIOUS INJURY AND INTERVENTION REQUIRED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION FROM THE USER FACILITY WERE MADE, HOWEVER NO RESPONSE FROM THE USER FACILITY RECEIVED AT THE TIME OF THIS REPORT. COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED AS NO SAMPLE WAS RETURNED FOR ANALYSIS. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED, AND NO RELEVANT FINDINGS WERE IDENTIFIED. WITHOUT THE DEVICE TO EVALUATE, THE COMPLAINT COULD NOT BE CONFIRMED, AND THE PROBABLE CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.

    Description of Event or Problem · 1

    MEDWATCH RECEIVED IN MORRISVILLE ON 11/05/2019. MW5090425. EVENT DESCRIPTION: A RIGHT INTERNAL JUGULAR CENTRAL LINE WAS PLACED FOR EMERGENT VASCULAR ACCESS; HOWEVER, WHILE THE NURSE PRACTITIONER (NP) WAS REMOVING THE GUIDEWIRE FROM THE PATIENT AND SHE NOTED THAT THE WIRE WAS UNUSUALLY MALFORMED AND HAD AN APPEARANCE OF A "SHREDDED VIOLIN WIRE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1173490 ARROW MULTI-LUMEN PI CVC KIT: 3-L 7 FR X 6" CATHETER INTRAVASCULAR THERAP FOZ ARROW INTERNATIONAL INC. 13F19F0362

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention