BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTINUOUS NERVE BLOCK KIT

    MDR report key: 2013785 · Received February 4, 2011

    Report

    Report Number
    1036844-2011-00038
    Event Type
    Malfunction
    Date Received
    February 4, 2011
    Date of Event
    January 12, 2011
    Report Date
    February 1, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CATHETER WAS BEING USED ON A FEMALE PATIENT FOR A LEFT TOTAL KNEE REPLACEMENT. THE CATHETER WAS PLACED WITHOUT INCIDENT AND USED FOR THE PROCEDURE. THE PATIENT WAS RECEIVING 20CC OF ROPIVACAINE 0.5% WITHOUT EPINEPHRINE AND 5CC OF 1.5% LIDOCAINE WITH EPINEPHRINE FOR TEST DOSE. AT WHICH TIME, THE ANESTHESIOLOGIST NOTICED THE CATHETER TO BE LEAKING. HE NOTICED A "SORT OF KNICK" IN THE CATHETER AT THE PROXIMAL END. THE PHYSICIAN THEN CUT THE PIECE OF CATHETER WHERE THE LEAKAGE WAS OCCURRING (FAR AWAY FROM THE PATIENT), THEREBY GETTING RID OF THE AREA THAT WAS CAUSING THE LEAK SO THE CATHETER WAS STILL ABLE TO BE USED AND ADMINISTER MEDICATION WITHOUT LEAKAGE. THE PATIENT RECEIVED SUCCESSFUL PAIN MANAGEMENT THAT WAS WELL CONTROLLED. THERE WAS NO DELAY IN TREATMENT, NO PATIENT DEATH AND NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTINUOUS NERVE BLOCK KIT ANESTHESIA PRODUCTS CAZ ARROW INTL., INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR