BEUDAMED
    FDA Adverse Event Other Summary report: N

    ARROW-HOWES

    MDR report key: 623613 · Received July 22, 2005

    Report

    Report Number
    623613
    Event Type
    Other
    Date Received
    July 22, 2005
    Date of Event
    July 14, 2005
    Report Date
    July 22, 2005
    Manufacturer
    ARROW INTERNATIONAL, INC.
    Product Code
    DQO
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A NURSE WAS PLACING A CVL CATHETER INTO A SIMULATION MANNEQUINN, AND NOTICED THAT THE SPRING WIRE GUIDE CUT THROUGH THE CATHETER. THE NURSE WAS USING AN ARROW 5.5 FR 3 LUMEN CENTRAL LINE CATHETER.PLEASE NOTE: THIS EVENT DID NOT INVOLVE A REAL PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARROW-HOWES VENOUS CATHETER KIT, FEMORAL VEIN INSERTION DQO ARROW INTERNATIONAL, INC. PRODUCT NUMBER: AK-14553 RF5033245

    Patients

    Seq Age Sex Outcome Treatment
    1 *