BEUDAMED
    FDA Adverse Event Other Summary report: N

    MCKESSON

    MDR report key: 1961734 · Received January 12, 2011

    Report

    Report Number
    1043646-2010-00001
    Event Type
    Other
    Date Received
    January 12, 2011
    Date of Event
    December 16, 2010
    Report Date
    January 12, 2011
    Manufacturer
    MEDEGEN MEDICAL PRODUCTS
    Product Code
    MMK
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT WAS REC'D ON (B)(6) 2010 FROM (B)(6) AT THE COMPLAINT UNIT FOR MEDEGEN MEDICAL PRODUCTS AND IMMEDIATELY ASSIGNED (B)(4). (B)(6) WAS CONTACTED ON SEVERAL OCCASIONS FOR FURTHER INFORMATION ON THE COMPLAINT AND TO REQUEST THAT THE COMPLAINED SHARPS CONTAINER BE RETURNED. EVALUATION: UPON RECEIPT OF THE COMPLAINED SHARPS CONTAINER ON (B)(4) 2011 IT WAS NOTED THAT LUMEN INJECTIONS WHICH WERE BEING DISCARDED IN COMPLAINED QUART SIZE SHARP CONTAINER WERE ALMOST AS TALL AS THE SHARPS CONTAINER AND PAST THE MARKED FILL MARK. FOUR PENETRATION TESTS WERE PERFORMED ON THE PERIMETER OF THE FAILURE OF THE COMPLAINED SHARPS CONTAINER (B)(4). THE WALL THICKNESS WAS ALSO MEASURED AT 0.06 INCHES. PHOTOGRAPHS WERE TAKEN OF THE COMPLAINED SHARPS CONTAINER AND LUMEN WHICH PENETRATED AND ARE ATTACHED FOR REVIEW. CONCLUSION: AFTER REVIEW AND TESTING OF THE COMPLAINED SHARPS CONTAINER IT APPEARS THAT THE CONTAINER WAS PENETRATED BY THE LUMEN INJECTION WHEN FORCED INTO THE TOO SMALL QUART SIZE SHARPS CONTAINER.

    Description of Event or Problem · 1

    A PT OF A GASTROENTEROLOGY PRACTICE RETURNED A FULL SHARPS CONTAINER TO THE GASTROENTEROLOGY PRACTICE FOR DISPOSAL. A NEEDLE WAS PROTRUDING THROUGH THE BOTTOM OF THE SHARPS CONTAINER AND A STAFF MEMBER WAS STUCK BY THE NEEDLE. THE STAFF MEMBER HAD BLOOD WORK DRAWN FOR TESTING AS THE PT IS A KNOWN (B)(6) PT. THE RESULTS OF THE BLOOD WORK HAVE NOT BEEN REPORTED TO OUR FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MCKESSON SHARPS CONTAINER MMK MEDEGEN MEDICAL PRODUCTS 101-8702 1798-211

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other