BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPIDURAL CATHETERIZATION KIT

    MDR report key: 3032964 · Received April 1, 2013

    Report

    Report Number
    1036844-2013-00121
    Event Type
    Malfunction
    Date Received
    April 1, 2013
    Date of Event
    March 20, 2013
    Report Date
    March 30, 2013
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    CAZ
    PMA / PMN Number
    K884552
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WILL NOT BE RETURNED FOR EVAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PROCEDURE WAS BEING PERFORMED ON A FEMALE PT IN LABOR AND DELIVERY. WHEN THE TRAY WAS OPENED, THEY FOUND THE GLASS SYRINGE WAS BROKEN. AS A RESULT, A NEW TRAY WAS USED FOR THE PT. THERE WAS NO DELAY IN TREATMENT AND NO PT DEATH OR COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    131666 EPIDURAL CATHETERIZATION KIT ANESTHESIA PRODUCTS CAZ ARROW INTERNATIONAL INC. RF2123280

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK