BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 3121653 · Received May 15, 2013

    Report

    Report Number
    3121653
    Event Type
    Malfunction
    Date Received
    May 15, 2013
    Date of Event
    May 2, 2013
    Report Date
    May 15, 2013
    Manufacturer
    ARROW INTERNATIONAL
    Product Code
    CAZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MT, US

    Narratives

    Description of Event or Problem · 1

    THE EPIDURAL WAS LEAKING JUST DISTAL TO THE CONNECTION HUB FOR THE PUMP TUBING. WE DISCONTINUED THE EPIDURAL BECAUSE THE PATIENT WAS SQUIRMING DOWN IN THE BED REPEATEDLY AND ENDED UP CURLING THE DRESSING AND DISLODGING THE EPIDURAL SOME DISTANCE. THERE IS A VERY TINY WIRE/HOLE PROTRUDING APPROXIMATELY 1-2 CM DISTAL TO THE BLUE/BLACK HUB. NOT SURE IF THIS IS A PRODUCT DEFECT OR BECAUSE OF THE PATIENT'S CONTINUED MOVEMENTS.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?EPIDURAL.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214454 * ANESTHESIA CONDUCTION KIT CAZ ARROW INTERNATIONAL AK-05000 *

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR