BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPINAL ANES/EPIDURAL CAT H KIT

    MDR report key: 2801091 · Received October 17, 2012

    Report

    Report Number
    1036844-2012-00296
    Event Type
    Malfunction
    Date Received
    October 17, 2012
    Date of Event
    October 4, 2012
    Report Date
    October 16, 2012
    Manufacturer
    ARROW INTERNATIONAL INC
    Product Code
    CAZ
    PMA / PMN Number
    K884552
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SAMPLE WILL NOT BE RETURNED.

    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 CONTENTS MOVED AROUND ENOUGH THAT AMPULES WERE BROKEN INCLUDING BUT NOT LIMITED TO THE SALINE AND LIDOCAINE VIALS. WHEN THIS OCCURS THEY ARE OPENING ANOTHER KIT AND USING IT FOR THE PROCEDURE. THERE WAS NO DELAY IN TREATMENT WITH NO HARM TO THE PT AND NO PT DEATH OR COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPINAL ANES/EPIDURAL CAT H KIT ANESTHESIA PRODUCTS CAZ ARROW INTERNATIONAL INC RM2082927

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK