BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW RADIAL ARTERY CATHETERIZATION SET

    MDR report key: 30194 · Received January 17, 1996

    Report

    Report Number
    30194
    Event Type
    Malfunction
    Date Received
    January 17, 1996
    Date of Event
    December 2, 1995
    Report Date
    December 20, 1995
    Manufacturer
    ARROW INTERNATIONAL, INC.
    Product Code
    DQO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THIS PRODUCT WAS USED IN STARTING A-LINE RIGHT WRIST BY CRNA. WIRE WOULD NOT WITHDRAW AFTER CATHETER IN POSITION. CATHETER AND WIRE REMOVED INTACT AND J WIRE BENT INTO TWO PLACES. SECOND RADIAL CATHETER KIT USED FIR CANNULATION. ANESTHESIA REQUESTED PRODUCT BE REPORTED TO MFR FOR DEFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARROW RADIAL ARTERY CATHETERIZATION SET ARROW RADIAL ARTERY CATHETERIZATION SET DQO ARROW INTERNATIONAL, INC. 201715

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR