BEUDAMED
    FDA Adverse Event Injury Summary report: N

    J-TIP NEEDLE FREE INJECTOR

    MDR report key: 2553738 · Received April 24, 2012

    Report

    Report Number
    MW5025181
    Event Type
    Injury
    Date Received
    April 24, 2012
    Date of Event
    April 19, 2012
    Report Date
    April 24, 2012
    Manufacturer
    NATIONAL MEDICAL PRODUCTS, INC.
    Product Code
    KZE
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2012, 13:39, (B)(6) PREVIOUSLY HEALTHY GIRL PRESENTED TO MGH ED WITH POSSIBLE EPISODE OF SEIZURE X 2. ASSESSED BY MD. AT 16:00 AN RN ADMINISTERS A J-TIP TO THE PT'S RIGHT HAND. AFTER APPROXIMATELY ONE MINUTE, SHE ATTEMPTED AN IV, GOT FLASH, BUT WAS ULTIMATELY NOT ABLE TO START THE IV. AT 16:08 A SECOND J-TIP WAS ADMINISTERED BY ANOTHER RN IN THE LEFT ANTECUBITAL. SHE STATES SHE POSITIONED THE J-TIP 2-3 CM DISTALLY TO WHERE SHE INTENDED TO START THE IV AS SHE WAS CONCERNED THE WHEAL MAY OBSCURE THE VEIN. THE IV WAS STARTED APPROXIMATELY 1-2 MINUTES AFTER THE J-TIP WAS ADMINISTERED. AT 18:00 LAB REPORTS POSITIVE FOR LIDOCAINE TOXICITY (5468 MCG/L REF. RANGE: 1500-5000 TOXIC: >6000). LAB RAN SECOND REPORT ON FIRST SAMPLE, WHICH REPORTEDLY STILL CAME BACK AT TOXIC LEVELS (APPROXIMATELY 10 MCG/L LESS THAN PREVIOUS REPORT). AT 18:55, REPEAT TOX SCREEN DRAWN FROM IV SITE. AT 19:56 LAB REPORT NEGATIVE FOR LIDOCAINE TOXICITY. (<150 MCG/L REF. RANGE: 1500-5000 TOXIC: >6000). AT 20:40 PT TRANSPORTED TO INPATIENT FLOOR. STRENGTH: 2 MG 1% LIDOCAINE BUFFERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 J-TIP NEEDLE FREE INJECTOR INJECTOR KZE NATIONAL MEDICAL PRODUCTS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 23 MO Hospitalization| L