BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    J-TIP SYRINGE

    MDR report key: 2765308 · Received September 19, 2012

    Report

    Report Number
    2027063-2012-00001
    Event Type
    Malfunction
    Date Received
    September 19, 2012
    Report Date
    August 19, 2012
    Manufacturer
    NATIONAL MEDICAL PRODUCTS, INC.
    Product Code
    KZE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ONE HUNDRED PERCENT INSPECTION VISUAL 100X MAGNIFICATION OF FILLED DEVICES RETURNED FROM PHARMACY; 76 UNITS - NINE UNITS SHOWED CRACKING - 152 UNITS IN ORIGINAL STERILE PACKAGING - OPENED 100% INSPECTION VISUAL 100X MAGNIFICATION - ZERO DEFECTS FOUND - ALL UNITS FILLED AND INSPECTED AT ZERO TIME - ZERO DEFECTS FOUND. TESTING OUTSIDE NORMAL STORAGE CONDITION IN PROCESS - WILL REPORT FOLLOWING COMPLETION OF TESTING. PREVIOUS LOT TESTING COULD ONLY REPLICATE THIS TYPE OF CRACKING WHEN UNITS WERE FILLED AND FROZEN.

    Description of Event or Problem · 1

    USER REPORTED MALFUNCTION, BREAKAGE OF DEVICE(S) AT USER ONE UNIT TIP BROKE, ONE UNIT CRACKED, ON UNIT WHERE THE FILLING UNIT ATTACHES BROKE OFF. NOT NORMAL PRACTICE BUT CANNOT REPORT THAT THE DEVICES WERE NOT STORED OUTSIDE LABELING STORAGE CONDITIONS. SYRINGE BROKE APART DURING ACTIVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 J-TIP SYRINGE SYRINGE, NEEDLESS KZE NATIONAL MEDICAL PRODUCTS, INC. J-TIP 0.25 ML 1205001

    Patients

    Seq Age Sex Outcome Treatment
    1