BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    J-TIP SYRINGE

    MDR report key: 3599280 · Received November 20, 2013

    Report

    Report Number
    2027063-2013-00001
    Event Type
    Malfunction
    Date Received
    November 20, 2013
    Date of Event
    May 21, 2013
    Report Date
    November 21, 2013
    Manufacturer
    NATIONAL MEDICAL PRODUCTS, INC.
    Product Code
    KZE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER HAS TESTED UNITS AND FOUND EXTREME HEAT (+ 140 DEGREES C) AND EXTREME COOLING (DRY ICE OR FREEZER STORAGE) CAN CAUSE DEVICE TO CRACK. THESE EXTREME TEMPERATURES ARE THE ONLY WAY THE MANUFACTURER COULD FIND CRACKING DAMAGE. NO ACTUAL "BREAKAGE" OCCURRED DURING TESTING BUT CRACKING OF THE MAIN BODY OF THE DEVICE WAS OBSERVED. ATTEMPT HAS BEEN MADE TO OBTAIN DEVICE. IF DEVICE IS RETURNED A FOLLOW-UP WILL BE FILED WITH FDA.

    Description of Event or Problem · 1

    USER REPORTED MALFUNCTION, BREAKAGE OR DEVICE (S) AT USE. (B)(4). "EVENT DESC: J-TIP "EXPLODED" WHILE BEING ADMINISTERED PRIOR TO PERIPHERAL IV PLACEMENT. PART OF THE J-TIP CLOSES TO END SHATTERED INTO MALL PIECES. MEDICATION DID NOT WORK AS INTENDED. DEFECTIVE J-TIP GIVEN TO ED PHARMACIST." NOT NORMAL PRACTICE BUT CANNOT REPORT THAT THE DEVICES WERE NOT STORED OUTSIDE LABELING STORAGE CONDITIONS. SYRINGE BROKE APART DURING ACTIVATION. PHARMACY LOT NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    604402 J-TIP SYRINGE SYRINGE, NEEDLESS KZE NATIONAL MEDICAL PRODUCTS, INC. J-TIP 0.25 ML UNK

    Patients

    Seq Age Sex Outcome Treatment
    1