BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUBLIX

    MDR report key: 5701826 · Received June 6, 2016

    Report

    Report Number
    2135402-2015-00012
    Event Type
    Malfunction
    Date Received
    June 6, 2016
    Date of Event
    November 17, 2015
    Report Date
    June 6, 2016
    Manufacturer
    ULTIMED, INC
    Product Code
    FMF
    PMA / PMN Number
    K062702
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUMMARY: CUSTOMER STATED HAD A NEEDLE STICK FROM ONE OF OUR BAGS OF PUBLIX INSULIN SYRINGES. THE CAP CAME OFF AND THE NEEDLE WAS EXPOSED, LOT # A50214, ITEM 192163 (B)(4). A TOTAL OF (B)(4) INNER BOXES WAS RECEIVED IN APRIL 2015. THE (B)(4) INNER BOX UNITS WERE SHIPPED OUT TO VARIOUS CUSTOMERS. NO PRODUCT WAS RETURNED WITH COMPLAINT. REVIEW OF INCOMING INSPECTION RECORDS INDICATED NO ISSUES WITH THIS LOT. NO OTHER COMPLAINTS ON THIS LOT. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    CUSTOMER STATED HAD A NEEDLE STICK FROM ONE OF OUR BAGS OF INSULIN SYRINGES. CAP CAME OFF AND NEEDLE WAS EXPOSED. LOT # A50214, ITEM # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    356931 PUBLIX 0.3CC, 31G X 5/16" U100 INSULIN SYRINGE FMF ULTIMED, INC A50214

    Patients

    Seq Age Sex Outcome Treatment
    1