BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ECLIPSE NEEDLE

    MDR report key: 6991727 · Received October 31, 2017

    Report

    Report Number
    2243072-2017-00206
    Event Type
    Injury
    Date Received
    October 31, 2017
    Date of Event
    March 29, 2017
    Report Date
    October 25, 2017
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. INVESTIGATION SUMMARY: AS BD LIFE SCIENCES - PREANALYTICAL SYSTEMS HAD NOT RECEIVED ANY SAMPLE, PHOTO, CATALOG NUMBER, AND/OR LOT NUMBER FROM THE CUSTOMER FACILITY FOR EVALUATION, AN INVESTIGATION COULD NOT BE PERFORMED AS NO INFORMATION WAS AVAILABLE FOR REVIEW. INVESTIGATION CONCLUSION: AS BD LIFE SCIENCES - PREANALYTICAL SYSTEMS HAD NOT RECEIVED ANY SAMPLE, PHOTO, CATALOG NUMBER, AND/OR LOT NUMBER FROM THE CUSTOMER FACILITY FOR EVALUATION, AN INVESTIGATION COULD NOT BE PERFORMED AS NO INFORMATION WAS AVAILABLE FOR REVIEW. ROOT CAUSE DESCRIPTION: AS BD LIFE SCIENCES - PREANALYTICAL SYSTEMS HAD NOT RECEIVED ANY SAMPLE, PHOTO, CATALOG NUMBER, AND/OR LOT NUMBER FROM THE CUSTOMER FACILITY FOR EVALUATION, AN INVESTIGATION COULD NOT BE PERFORMED AS NO INFORMATION WAS AVAILABLE FOR REVIEW.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SAFETY SHIELD FELL OFF DURING USE ON A UNKNOWN ECLIPSE NEEDLE RESULTING IN NEEDLE STICK INJURY. MEDICAL INTERVENTION UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    770685 UNKNOWN ECLIPSE NEEDLE SAMPLE NEEDLE FMI BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other