BEUDAMED
    FDA Adverse Event Other Summary report: N

    J-TIP SYRINGE

    MDR report key: 1943500 · Received October 29, 2010

    Report

    Report Number
    2027063-2010-00001
    Event Type
    Other
    Date Received
    October 29, 2010
    Date of Event
    September 20, 2010
    Report Date
    October 29, 2010
    Manufacturer
    NATIONAL MEDICAL PRODUCTS, INC.
    Product Code
    KZE
    PMA / PMN Number
    K980082
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT PROBLEM TYPE HAS NEVER BEFORE BEEN REPORTED - OVER 4 MILLION UNITS DISTRIBUTED. DISCUSSION WITH REPORTING NURSE SHE STATED IT WAS A USER ERROR AS WELL AS MEDWATCH REPORT COPIED TO MANUFACTURER.

    Description of Event or Problem · 1

    NURSE WENT TO APPLY J-TIP. STATES SHE APPLIED J-TIP APPROPRIATELY AND THE LIDOCAINE SPRAYED AT LEASE 12 INCHES AND SPLASHED HER IN BOTH EYES. NURSE WAS SEEN IN ASSOCIATE HEALTH DEPARTMENT. NO NEGATIVE SEQUELAE NOTED TO DATE FROM SPLASH INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 J-TIP SYRINGE SYRINGE, NEEDLELESS KZE NATIONAL MEDICAL PRODUCTS, INC. J-TIP .50 ML 1003001

    Patients

    Seq Age Sex Outcome Treatment
    1 Other