BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHARPS COMPLIANCE INC, 13000, 3 GALLON

    MDR report key: 3566415 · Received November 22, 2013

    Report

    Report Number
    3007508552-2013-00003
    Event Type
    Malfunction
    Date Received
    November 22, 2013
    Date of Event
    October 23, 2013
    Report Date
    November 22, 2013
    Manufacturer
    SHARPS COMPLIANCE INC.
    Product Code
    MMK
    PMA / PMN Number
    K083129
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION OF ACTUAL CONTAINER NOT POSSIBLE DUE TO CONTAINER NOT RETURNED TO MFR. AFTER 29 DAYS, THEY HAVE YET TO RETURN THE CONTAINER. AT SUCH A TIME AS (B)(6) RETURNS 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 OVERFILLED THAT LEADS TO NEEDLE PROTRUSIONS.

    Description of Event or Problem · 1

    (B)(6) CALLED FROM (B)(6) TO ADVISE THAT SHE GOT POKED BY A NEEDLE THAT WENT THROUGH THE SIDE OF A SHARPS CONTAINER. SHE STATES THAT THE NEEDLE POKED THROUGH ABOUT 1 INCH BELOW THE LID OF THE 3 GALLON CONTAINER. SHE STATES THAT THE NEEDLE WAS PLACED INTO THE CONTAINER A FEW DAYS BEFORE. SHE WAS REACHING FOR THE CONTAINER AND SHE GOT POKED BY THE NEEDLE. SHE DID NOT KNOW IF THE NEEDLE STUCK INTO HER OR JUST GRAZED HER SKIN. SHE SOUGHT EMERGENCY MEDICAL ATTENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610064 SHARPS COMPLIANCE INC, 13000, 3 GALLON SHARPS CONTAINER MMK SHARPS COMPLIANCE INC. 13000 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization