BEUDAMED
    FDA Adverse Event Injury Summary report: N

    J-TIP NEEDLE FREE INJECTION SYSTEM . 2ML

    MDR report key: 2583825 · Received May 16, 2012

    Report

    Report Number
    MW5025439
    Event Type
    Injury
    Date Received
    May 16, 2012
    Date of Event
    May 14, 2012
    Report Date
    May 16, 2012
    Manufacturer
    NATIONAL MEDICLA PRODUCTS, INC.
    Product Code
    KZE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A (B)(6) MALE WITH A PMHX SIGNIFICANT FOR SPHEROCYTOSIS PRESENTED TO THE ED ON (B)(6), WITH ATAXIA. HE WAS ADMINISTERED A J-TIP IN THE R AC PRIOR TO IV START AT 23:22. LABS WERE SENT AND THE TOX SCREEN CAME BACK POSITIVE FOR LIDOCAINE TOXIC LEVEL OF 7238, RANGE OF 1500-5000 AND CLONAZEPAM. A SECOND TOX SCREEN WAS SENT AT 04:45 WHICH CAME BACK NEGATIVE FOR LIDOCAINE. OF NOTE, THE PT WAS TRANSFERRED TO THE PICU FOR A CODE EVENT AT 4:45 WHERE HE BECAME UNRESPONSIVE. THIS OCCURRED SHORTLY AFTER THE 2ND SET OF LABS WERE DRAWN FOR REPEAT TOX SCREEN. HPI: MOTHER TAKES GAPAPENTIN, KLOPAZEPAM, TOPAMAX; (B)(6) LIVES IN HOUSE ALSO WHILE SHE IS DEALING WITH CANCER, HAS MANY MEDS THAT MOM DOESN'T KNOW OF, BUT KEEPS THEM ALL UP AS WELL. PMHX/PSHX: SPHEROCYTOSIS, FOLLOWED BY PRIMARY CARE, DX WITH YELLOW EYES AT AN OPHTHO VISIT LAST YEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 J-TIP NEEDLE FREE INJECTION SYSTEM . 2ML J-TIP 1% KZE NATIONAL MEDICLA PRODUCTS, INC. 05102012@552
    2 J-TIP NEEDLE FREE INJECTION SYSTEM .2ML J-TIP 1% KZE NATIONAL MEDICAL PRODUCTS, INC. 04232012@50

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR Hospitalization