BEUDAMED
    FDA Adverse Event Other Summary report: N

    SHARPS 1 GALLON

    MDR report key: 3651414 · Received February 21, 2014

    Report

    Report Number
    3007508552-2014-00001
    Event Type
    Other
    Date Received
    February 21, 2014
    Date of Event
    April 10, 2013
    Report Date
    February 13, 2014
    Manufacturer
    SHARPS COMPLIANCE
    Product Code
    MMK
    PMA / PMN Number
    K942179
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, 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 REVIEW OF PREVIOUS NEEDLE PROTRUDING FROM CONTAINER REPORTS IT IS USUALLY THE CONTAINER BEING OVER-FILLED THAT LEADS TO NEEDLE PROTRUSIONS.

    Description of Event or Problem · 1

    ON (B)(6) 2014, SHARPS COMPLIANCE RECEIVED NOTIFICATION THAT ON (B)(6) 2013, (B)(6) WAS THROWING AWAY A SHARPS CONTAINER AND WAS POKED BY A NEEDLE. THE INCIDENT REQUIRED (B)(6) TO SEEK MEDICAL ATTENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108843 SHARPS 1 GALLON SHARPS CONTAINER MMK SHARPS COMPLIANCE 61000 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization