BEUDAMED
    FDA Adverse Event Other Summary report: N

    SHARPS COMPLIANCE INC.

    MDR report key: 4818932 · Received June 1, 2015

    Report

    Report Number
    3007508552-2015-00002
    Event Type
    Other
    Date Received
    June 1, 2015
    Date of Event
    May 6, 2015
    Report Date
    May 28, 2015
    Manufacturer
    SHARPS COMPLIANCE INC.
    Product Code
    MMK
    PMA / PMN Number
    K083129
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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 05/07/2015, (B)(6) CONTACTED SHARPS CUSTOMER SVC AND REPORTED THE FOLLOWING: WHILE PREPARING 2 GALLONS SHARPS CONTAINER FOR SHIPMENT, REDICLINIC EMPLOYEE WAS STUCK BY NEEDLE PROTRUDED THROUGH BOTTOM OF CONTAINER. THE CONTAINER WAS 2 GALLON WITH MANIFEST NUMBER 3748658. (B)(6), VP OF QUALITY CONTACTED (B)(6) AND WAS ABLE TO CONFIRM THAT THE CONTAINER WAS 2 GALLON SHARPS COMPLIANCE MODEL. (B)(6) ALSO INDICATED EMPLOYEE WHO CAME IN CONTACT WITH CONTAINER HAS BEEN ASKED TO SEEK MEDICAL ADVICE. (B)(6) INSTRUCTED (B)(6) TO QUARANTINE THE CONTAINER, SHARPS WILL SHIP CONTAINMENT SYSTEM TO RETRIEVE AND PERFORM INVESTIGATION IN AN EFFORT TO DETERMINE ROOT CAUSE. ON 05/08/2015, (B)(6) FROM SHARPS COMPLIANCE CUSTOMER SVC SHIPPED CONTAINMENT SYSTEM TO REDICLINIC. ON 05/14/2015 SHARPS ENVIRONMENTAL SVS RECEIVED THE CONTAINMENT SYSTEM SENT TO REDICLINIC TO RETRIEVE THE SUSPECT 2 GALLON CONTAINER. UNFORTUNATELY THE CUSTOMER REMOVED THE MANIFEST, (WHICH WAS LOGGED TO BE HELD), AND THE CONTAINMENT SYSTEM WAS TREATED, RENDERING THE SYSTEM NOT SUITABLE FOR INSPECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353455 SHARPS COMPLIANCE INC. SHARPS CONTAINER MMK SHARPS COMPLIANCE INC. 82000 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other