BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHARPS COMPLIANCE, INC.

    MDR report key: 8032236 · Received November 2, 2018

    Report

    Report Number
    3007508552-2015-00001
    Event Type
    Injury
    Date Received
    November 2, 2018
    Date of Event
    December 4, 2015
    Report Date
    November 1, 2018
    Manufacturer
    SHARPS COMPLIANCE, INC.
    Product Code
    FMI
    PMA / PMN Number
    K945275
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SHARPS PRODUCT PACKAGING FACILITY, LOCATED AT (B)(4) DOES NOT ALLOW FOR CONTAMINANTS IN PRODUCT PACKAGING AREAS. CONTAINERS ARE WRAPPED IN PLASTIC FROM THE SUPPLIER, UNTIL THEY REACH THE PRODUCT PACKAGING AREA. CONTAINERS ARE THEN INSPECTED FOR AN ABSORBENT PAD, AND TO MAKE SURE THERE ARE NO CONTAMINANTS IMMEDIATELY PRIOR TO BEING PLACED INTO A 4 MIL PLASTIC BAG AND THEN INTO CORRUGATE PACKAGING. PACKAGED PRODUCT IS PALLETIZED AND MOVED TO A FINISHED GOOD LOCATION UNTIL NEEDED FOR SHIPPING. PRODUCT PACKAGING IS SUPERVISED BY A LINE LEADER AND NUMEROUS LINE WORKERS. AT NO POINT FOLLOWING PRODUCT PACKAGING IS THE 4 MIL PLASTIC BAG OPENED UNTIL REACHING THE CUSTOMER OR DISTRIBUTOR. AT NO POINT IN THE PRODUCT PACKAGING PROCESS IS THERE A POTENTIAL FOR CONTAMINANTS TO BE PLACED INTO SHARPS CONTAINERS. SHARPS DOES NOT TREAT USED CONTAINERS/SYSTEMS AT THEIR PRODUCT PACKAGING FACILITY.

    Description of Event or Problem · 1

    ON (B)(6) 2014 THE INDIVIDUAL PURCHASED A SHARPS NEEDLE COMPLETE SYSTEM FROM (B)(6). THE INDIVIDUAL CLAIMS THE CONTAINER WAS USED AND FULL OF NEEDLES. THE INDIVIDUAL ALSO CLAIMS THE CONTAINER OPENING WAS DISGUISED WITH PAPER, OVER THE DEPOSIT ENTRANCE AND AS A RESULT THE INDIVIDUAL WAS STUCK WITH A NEEDLE. THE INCIDENT WAS REPORTED TO SHARPS COMPLIANCE ON 3/6/2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    873472 SHARPS COMPLIANCE, INC. SHARPS CONTAINER FMI SHARPS COMPLIANCE, INC. 100575

    Patients

    Seq Age Sex Outcome Treatment
    1 Other