BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NA

    MDR report key: 3032501 · Received April 1, 2013

    Report

    Report Number
    1036844-2013-00113
    Event Type
    Injury
    Date Received
    April 1, 2013
    Date of Event
    March 8, 2013
    Report Date
    March 27, 2013
    Manufacturer
    ARROW INTL., INC.
    Product Code
    CAZ
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS DISCARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT OB, DURING THE INSERTION OF THE EPIDURAL CATHETER, THE FEMALE PT ENDURED A "WET TAP", ACCIDENTAL PUNCTURE OF THE DURA MATER DURING INJECTION OF EPIDURAL ANESTHESIA, WHICH IN TURN LEAD TO A SEVERE HEAD ACHE. AS A RESULT, A BLOOD PATCH WAS REQUIRED. DAYS LATER, THIS PT REQUIRED A SECOND BLOOD PATCH AND IS NOW DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    132897 NA ANESTHESIA PRODUCTS CAZ ARROW INTL., INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention BLOOD PATCH