BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARROW

    MDR report key: 6307715 · Received February 3, 2017

    Report

    Report Number
    MW5067711
    Event Type
    Injury
    Date Received
    February 3, 2017
    Date of Event
    January 4, 2017
    Report Date
    February 3, 2017
    Manufacturer
    ARROW
    Product Code
    FOZ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PATIENT PRESENTED FOR MINI MR, PMH SEVERE MR, MVP, MILD ASTHMA, HTN, HLD, NSTEMI IN 2012, NKDA, LATEX ALLERGIC, ANESTHESIA INDUCTION/INTUBATION WITHOUT INCIDENT. A 9F DOUBLE LUMEN CATHETER INSERTED IN RIJ, WITH QUICK HYPOTENSION, TACHYCARDIA, FACIAL RASH. CATHETER REMOVED, TREATED WITH EPINEPHRINE, VASOPRESSIN, BENADRYL, HYDROCORTISONE. TRYPTASE ELEVATED. CASE CANCELLED. CATHETER CHECKED- LATEX FREE. +CHG COATED, SILVER SULFADINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84054 ARROW MAC DOUBLE LUMEN CATHETER FOZ ARROW

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Life Threatening| O