BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHARPS 3 GALLON

    MDR report key: 4170550 · Received October 2, 2014

    Report

    Report Number
    3007508552-2014-00002
    Event Type
    Injury
    Date Received
    October 2, 2014
    Date of Event
    September 8, 2014
    Report Date
    December 12, 2018
    Manufacturer
    SHARPS COMPLIANCE, INC.
    Product Code
    MMK
    PMA / PMN Number
    K083129
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION OF ACTUAL CONTAINER NOT POSSIBLE DUE TO CONTAINER NOT RETURNED TO MANUFACTURER. AT SUCH A TIME AS SHARPS RECEIVES THE CONTAINER SHARPS WILL PERFORM AN INVESTIGATION, INCLUDING BUT NOT LIMITED TO THE WALL THICKNESS OF THE SECTION OF THE CONTAINER WHERE THE NEEDLE IS PROTRUDING. 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 THE 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) 2014 AT 9 AM, (B)(6), (WITH (B)(6)), CALLED IN TO REPORT AN INCIDENT. CUSTOMER WAS CARRYING SHARPS CONTAINER BACK TO PHARMACY AND ACCIDENTLY BUMPED LEG INTO BOTTOM OF CONTAINER AND CUSTOMER WAS POKED BY NEEDLE THAT WAS PROTRUDING OUT OF THE BOTTOM OF THE CONTAINER. CONTAINER HAS BEEN PLACED IN A SECURE AREA SO NO ONE CAN ACCESS IT. CUSTOMER DID SEE A DOCTOR AND SHE HAS TAKEN A BLOOD TEST. SHE IS CURRENTLY AWAITING RESULTS OF THIS TEST TO MAKE SURE NO INFECTION OR DISEASE WAS INJECTED INTO HER SYSTEM. PER A1 WE WILL SEND OUT CUSTOMER ITEM 12801 - 28 GALLON MEDICAL PROFESSIONAL SHARPS RECOVERY SYSTEM SO THAT THE CONTAMINATED CONTAINER CAN BE SENT BACK FOR QUALITY INSPECTION. AS OF (B)(6) 2014, THE CONTAINER HAS NOT BEEN RETURNED TO SHARPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    616761 SHARPS 3 GALLON SHARPS CONTAINER MMK SHARPS COMPLIANCE, INC. 13000 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other