BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    J-TIP SYRINGE

    MDR report key: 2347605 · Received November 9, 2011

    Report

    Report Number
    2027063-2011-00001
    Event Type
    Malfunction
    Date Received
    November 9, 2011
    Date of Event
    October 11, 2011
    Report Date
    October 8, 2011
    Manufacturer
    NATIONAL MEDICAL PRODUCTS, INC.
    Product Code
    KZE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT WAS FILLED WITH MEDICATION BY THIRD PARTY SOURCE AND SHIPPED TO HOSPITAL (USER). PRODUCT WAS EVALUATED AND MFR COULD ONLY DUPLICATE REPORTED EVENT FOLLOWING STORAGE OF PRODUCT (FILLED WITH MEDICATION) OUTSIDE LABELED STORAGE CONDITIONS. AT THIS TIME MFR BELIEVES PRODUCT WAS STORED (FROZEN) AFTER FILLING AND PRIOR TO USE, CAUSING CRACKING AND WHEN DEVICE WAS ACTIVATED PRODUCT BROKE. PRODUCT LABELING AND INSTRUCTIONS FOR USE STATE RANGE PRODUCT MUST BE STORED AND TO INSPECT PRODUCT FOR DAMAGE PRIOR TO USE. IT IS THE UNDERSTANDING OF THE MFR THAT THE THIRD PARTY PHARMACY SHIPS PRODUCT WITH COLD PACKS (ICE) AND PRODUCT MAY HAVE BEEN STORED REFRIGERATED AT USER.

    Description of Event or Problem · 1

    SYRINGE BROKE APART DURING ACTIVATION. INJURY TO PERSONNEL USING DEVICE REQUIRED STITCHES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 J-TIP SYRINGE SYRINGE, NEEDLES KZE NATIONAL MEDICAL PRODUCTS, INC. J-TIP 0.25 ML 1104001

    Patients

    Seq Age Sex Outcome Treatment
    1