BEUDAMED
    FDA Adverse Event Injury Summary report: N

    21 G X 1.25 IN BD ECLIPSE¿ BLOOD COLLECTION NEEDLE WITH LUER ADAPTER

    MDR report key: 6035442 · Received October 17, 2016

    Report

    Report Number
    1024879-2016-00044
    Event Type
    Injury
    Date Received
    October 17, 2016
    Date of Event
    September 29, 2016
    Report Date
    November 3, 2016
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    FMI
    PMA / PMN Number
    K982541
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DATE OF EVENT IS UNKNOWN BUT IT DID OCCUR IN (B)(6) 2016. THE DATE RECEIVED BY THE MANUFACTURER IS USED. (B)(4). DEVICE EVALUATION: A SAMPLE IS AVAILABLE FOR EVALUATION. A SUPPLEMENTAL REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: RESULT - A SAMPLE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR THE REPORTED LOT 6083662, CATALOG 367607. PRODUCT WAS MANUFACTURED AT THE BD (B)(4) SITE MARCH 2016. ALL INSPECTIONS WERE IN COMPLIANCE WITH REQUIREMENTS. CONCLUSION - BD WAS UNABLE TO CONFIRM THE CUSTOMER'S COMPLAINT. WITHOUT A SAMPLE AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE SAFETY MECHANISM OF THE SUSPECT DEVICE SNAPPED OFF AS IT WAS BEING PUSHED OVER THE NEEDLE WITH THE THUMB. THE CLINICIAN HAD BLOOD SPLATTER TO HER FACE AS A RESULT OF THIS INCIDENT. SHE USED THE EYE WASH STATION AND IS BEING FOLLOWED BY THE FACILITY'S EMPLOYEE HEALTH. THERE WAS NO OTHER INTERVENTION AND NO ALTERATION OF PATIENT CARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    685334 21 G X 1.25 IN BD ECLIPSE¿ BLOOD COLLECTION NEEDLE WITH LUER ADAPTER SAMPLE NEEDLE FMI BECTON, DICKINSON & CO., (BD) 6083662

    Patients

    Seq Age Sex Outcome Treatment
    1 Other