BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTINUOUS NERVE BLOCK KIT

    MDR report key: 3190546 · Received June 21, 2013

    Report

    Report Number
    1036844-2013-00205
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    May 24, 2013
    Report Date
    June 20, 2013
    Manufacturer
    ARROW INTL., INC.
    Product Code
    CAZ
    PMA / PMN Number
    K021567
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS NOT BEING RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE ANESTHESIA TECH HAS HAD A PERSISTENT PROBLEM WITH THE GLASS VIALS OF MEDICATION IN HIS KIT. IN SEVERAL INSTANCES, HE HAS CUT HIS FINGERS WHEN "POPPING" OPEN THE VIALS OF 1% LIDOCAINE. HE HAS ATTEMPTED TO EMPLOY ALL METHODS OF SAFETY INCLUDING DOUBLE GLOVES, USING A FOLDED 2X2 GAUZE PAD FOR PROTECTION, AND CRACKING OPEN THE VIAL AWAY FROM HIS BODY; HOWEVER, ALL INSTANCES OF INJURY OCCURRED UNDER THESE SAFETY OBSERVATIONS. HE DOES NOT KNOW HOW MANY TIME HE HAS CUT HIMSELF. IT IS NOT KNOWN IF THIS CAUSED A DELAY IN TREATMENT TO THE PT AND THERE WAS NO PT DEATH OR COMPLICATIONS REPORTED. THERE WAS NO MEDICAL INTERVENTION REQUIRED BY THE ANESTHESIA TECH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282682 CONTINUOUS NERVE BLOCK KIT ANESTHESIA PRODUCTS CAZ ARROW INTL., INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK