BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARROW

    MDR report key: 1192210 · Received October 8, 2008

    Report

    Report Number
    MW5008581
    Event Type
    Injury
    Date Received
    October 8, 2008
    Date of Event
    September 10, 2008
    Report Date
    September 26, 2008
    Manufacturer
    ARROW INTERNATIONAL, INC.
    Product Code
    CAZ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A 12 CM PIECE OF THE EPIDURAL CATHETER BROKE OFF DURING REMOVAL, AND REMAINS IN THE PT, IN THE SUBCUTANEOUS TISSUE OF THE BACK IN THE MIDLINE PASSING BETWEEN THE L3 AND L4 SPINOUS PROCESSES, AND ENTERING THE SPINAL CANAL, WHERE IT IS COILED SOMEWHAT AT THE L3 LEVEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARROW EPIDURAL CATHETERIZATION KIT WITH FLEXTIP PLUS CATHETER CAZ ARROW INTERNATIONAL, INC. SJ-05501

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization