BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EPIDURAL CATHETERIZATION KIT

    MDR report key: 2971320 · Received February 15, 2013

    Report

    Report Number
    1036844-2013-00061
    Event Type
    Injury
    Date Received
    February 15, 2013
    Date of Event
    December 11, 2012
    Report Date
    February 15, 2013
    Manufacturer
    ARROW INTL., INC.
    Product Code
    CAZ
    PMA / PMN Number
    K884552
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THIS EVENT WAS FOUND VIA THE MONTHLY REVIEW OF THE MAUDE DATABASE. THE CATHETER WAS PLACED FOR LABOR AND DELIVERY. DURING REMOVAL OF THE CATHETER, IT WAS FOUND THAT THE CATHETER WAS NOT INTACT. A FRAGMENT WAS CONFIRMED, BY LUMBER CT SCAN AND THE FRAGMENT WAS SURGICALLY REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69442 EPIDURAL CATHETERIZATION KIT ANESTHESIA PRODUCTS CAZ ARROW INTL., INC. RF2072310

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention