BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEROYAL

    MDR report key: 3760956 · Received April 10, 2014

    Report

    Report Number
    3005225477-2014-00005
    Event Type
    Injury
    Date Received
    April 10, 2014
    Date of Event
    November 29, 2013
    Report Date
    December 6, 2013
    Manufacturer
    DEROYAL GUATEMALA
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DESCRIBE EVENT OR PROBLEM: THE MEDICAL CENTER REPORTED THAT WHEN THE HEALTH PROFESSIONAL WAS PLACING CONTAINER IN SHARPS BIN, THE NEEDLE COUNTER BOX CAME APART LEAVING A GAP THROUGH WHICH A SHARP OBJECT PROTRUDED AND PIERCED THE SKIN OF THEIR FINGER. DEROYAL: THE SAMPLE WAS NOT RETURNED FOR EVALUATION. INVENTORY WAS REVIEWED AND FOUND TO BE ACCEPTABLE. THE REPORT WAS DETERMINED TO BE AN ISOLATED INCIDENT DUE TO AN UNDETERMINED ROOT CAUSE. IT IS UNKNOWN IF AN END USER OR DEROYAL MANUFACTURING ERROR OCCURRED.

    Description of Event or Problem · 1

    THE MEDICAL CENTER REPORTED THAT WHEN THE HEALTH PROFESSIONAL WAS PLACING CONTAINER IN SHARPS BIN, THE NEEDLE COUNTER BOX CAME APART LEAVING A GAP THROUGH WHILE A SHARP OBJECT PROTRUDED AND PIERCED THE SKIN OF THEIR FINGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216364 DEROYAL INSTRUMENT, SURGICAL, DISPOSABLE FMI DEROYAL GUATEMALA 32280730

    Patients

    Seq Age Sex Outcome Treatment
    1 Other