BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPIDURAL CATHETERIZATION COMP

    MDR report key: 1052547 · Received May 22, 2008

    Report

    Report Number
    1036844-2008-00078
    Event Type
    Malfunction
    Date Received
    May 22, 2008
    Date of Event
    September 19, 2007
    Report Date
    May 22, 2008
    Manufacturer
    ARROW INTERNATIONAL INC
    Product Code
    CAZ
    PMA / PMN Number
    K884552
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    A SEARCH OF ARROW DATABASES INDICATED THAT INFO HAD NOT BEEN RECEIVED CONCERNING THIS EVENT. FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    AN EMAIL WAS RECEIVED. REPORTER STATES THAT IT IS THEIR UNDERSTANDING THAT THE INCIDENT WAS ALSO REPORTED TO ARROW. IT WAS REPORTED THAT "IN THE MIDDLE OF THE NIGHT THE BEDSIDE NURSE FOUND LARGE WET AREA. NOTED THAT THE EPIDURAL CATHETER HAD A SMALL FRACTURE AT THE PROXIMAL END AND THE FLUID WAS LEAKING OUT."REGIONAL HEALTH AUTHORITY (WHRA) FILE. THE INCIDENT OCCURRED IN 2007. THE PACKAGING WAS DISCARDED BY THE HOSPITAL, AND NO LOT NUMBER WAS RECORDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EPIDURAL CATHETERIZATION COMP ANESTHESIA PRODUCTS CAZ ARROW INTERNATIONAL INC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK