BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPINAL ANESTHESIA KIT

    MDR report key: 2193456 · Received July 13, 2011

    Report

    Report Number
    1036844-2011-00228
    Event Type
    Malfunction
    Date Received
    July 13, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 12, 2011
    Manufacturer
    ARROW INTL., INC.
    Product Code
    CAZ
    PMA / PMN Number
    K021567
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FOLLOW UP REPORT WILL BE FILED IF ADD'L INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE IN THE OPERATING ROOM (OR) THE PT WAS GIVEN GENERAL ANESTHESIA. THE SPINAL CATHETER WAS INSERTED VIA THE LUMBAR AREA. AFTER THE SPINAL CATHETER WAS INSERTED THE PT CONTINUED TO FEEL PAIN. AS A RESULT, THE MD PROCEEDED WITH GENERAL ANESTHESIA. THERE WAS NO REPORTED PT DEATH OR INJURY. MEDICAL/SURGICAL INTERVENTION WAS NOT REQUIRED. THERE WAS A DELAY/INTERRUPTION IN THERAPY, HOWEVER THERE WAS NO HARM TO THE PT. THERE WERE NO PT COMPLICATIONS AND THE PT OUTCOME IS LISTED AS "PT RECEIVED GENERAL ANESTHESIA."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPINAL ANESTHESIA KIT ANESTHESIA PRODUCTS CAZ ARROW INTL., INC. RF0074417

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR