BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHARPS COMPLIANCE, INC.

    MDR report key: 8032235 · Received November 2, 2018

    Report

    Report Number
    3007508552-2016-00001
    Event Type
    Injury
    Date Received
    November 2, 2018
    Date of Event
    June 7, 2016
    Report Date
    November 1, 2018
    Manufacturer
    SHARPS COMPLIANCE, INC.
    Product Code
    FMI
    UDI-DI
    00634188000905
    PMA / PMN Number
    K945275
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    501

    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. ALL SHARPS CONTAINERS ARE PUNCTURE RESISTANT, NOT PUNCTURE PROOF. PRODUCT LABELING ON THE CONTAINER STATES "CONTAINERS ARE PUNCTURE RESISTANT, NOT NECESSARILY PUNCTURE PROOF", AND INSTRUCTIONS FOR USE STATE "DO NOT OVERFILL (FILL LINE IS NOTED ON CONTAINER LABEL). LID MUST FIT DOWN TIGHTLY." BASED ON REVIEW OF PREVIOUS NEEDLE PROTRUDING FROM CONTAINER REPORTS IT IS USUALLY THE CONTAINER BEING OVERFILLED THAT LEADS TO NEEDLE PROTRUSIONS.

    Description of Event or Problem · 1

    ON (B)(6) 2016 AT 4: PM - (B)(6) FROM (B)(6) CALLED (B)(4) AT SHARPS COMPLIANCE, INC., CUSTOMER SUPPORT AND STATED 3-GALLON REPLACEMENT RETURN BOX RECEIVED AND IT INCLUDED A 1 QUART SHARPS CONTAINER MANIFEST (B)(4). SHE ALSO STATED THAT SHE WAS STUCK BY A NEEDLE THAT PROTRUDED THROUGH THE 1-QUART CONTAINER. ON (B)(4) 2016 AT 4:15 PM - (B)(4) CONTACTED (B)(4) OF QUALITY AT SHARPS COMPLIANCE, INC., (B)(4) INSTRUCTED (B)(4) TO CONTACT (B)(6) AT (B)(6) AND EXPLAIN THE FOLLOWING: (B)(6) SHOULD SEEK MEDICAL ATTENTION AND INFORM (B)(6)'S SAFETY OFFICER OF THIS INCIDENT. SHARPS TO SHIP A LARGER CONTAINMENT SYSTEM TO RETRIEVE THE SUSPECTED CONTAINER FOR FURTHER INVESTIGATION. UPON RECEIPT OF RETURNED CONTAINER, SHARPS WILL INVESTIGATE AND THE RESULTS OF THAT INVESTIGATION WILL BE REPORTED TO (B)(6). ON (B)(4) 2016 - REVIEW OF SHARPS ENVIRONMENTAL SERVICES TREATMENT RECORDS SHOW THAT THE SYSTEM IN QUESTION WAS RETURNED DIRECTLY TO SHARPS ENVIRONMENTAL SERVICES (B)(4), (TREATMENT FACILITY) AND TREATED ON (B)(4) 2016, INSTEAD OF BEING RETURNED TO SHARPS COMPLIANCE FOR INSPECTION IN THE PROVIDED, POSTAGE PREPAID 20-GALLON RETURN SYSTEM. NO FURTHER INSPECTION POSSIBLE. ON (B)(6) 2016 ABOUT 11:10 - (B)(6) RETURNED CONTACTED MR. (B)(4) (FROM PHONE # (B)(6)) AND EXPLAINED THE FOLLOWING: WHILE ATTEMPTING TO PLACE THE 1 QUART CONTAINER INSIDE THE 3 GALLON MAILBACK BOX SHE WAS STUCK BY A NEEDLE PROTRUDING "THRU" THE CONTAINER AND SHE WAS ABLE TO SEEK MEDICAL HELP. THE NEEDLE STUCK HER RIGHT HAND INDEX FINGER. (B)(6) ALSO EXPLAINED THAT HER POSITION IS (B)(6) AND STATED "I AM NOT FAMILIAR THE CONTAINERS OR HOW TO SHIP BACK".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    873471 SHARPS COMPLIANCE, INC. SHARPS CONTAINER FMI SHARPS COMPLIANCE, INC. 100015 00634188000905

    Patients

    Seq Age Sex Outcome Treatment
    1 Other