BEUDAMED
    FDA Adverse Event Other Summary report: N

    J-TIP

    MDR report key: 2288213 · Received October 5, 2011

    Report

    Report Number
    MW5022565
    Event Type
    Other
    Date Received
    October 5, 2011
    Date of Event
    October 4, 2011
    Report Date
    October 5, 2011
    Manufacturer
    AMERIDOSE
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    THE PLASTIC, CONE SHAPED NOZZEL ON A J-TIP NEEDLESS INJECTION DEVICE BROKE OFF FROM THE DEVICE WHEN THE CO2 CANNISTER WAS ACTIVATED. THE PATIENT DID NOT RECEIVE ADEQUATE ANALGESIA AT THE SITE OF ADMINISTRATION. RESULT WAS PAINFUL VENIPUNCTURE. PACKAGED BY (B)(4), MFR (B)(4)-IRVINE. LIDOCAINE 1% BUFFERED: DOSE OR AMOUNT: 0.25 ML, FREQUENCY: ONCE, ROUTE: SUBCUTANEOUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 J-TIP J-TIP FMF AMERIDOSE 8164-2001-25 09152011@391

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Other