BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD ECLIPSE¿ NEEDLE

    MDR report key: 8624491 · Received May 20, 2019

    Report

    Report Number
    8041187-2019-00391
    Event Type
    Injury
    Date Received
    May 20, 2019
    Date of Event
    May 1, 2019
    Report Date
    June 11, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FMI
    UDI-DI
    30382903057611
    PMA / PMN Number
    K161170
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION:A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED NO NON-CONFORMANCE'S ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. A REVIEW OF PAST 12 MONTHS QUALITY NOTIFICATION WERE PERFORMED AND NO QUALITY NOTIFICATION WAS RAISED ON THE REPORTED DEFECT. THE REPORTED DEFECT CANNOT BE CONFIRMED AS NO PHOTOS / SAMPLES WERE RETURNED FOR EVALUATION. THEREFORE, ROOT CAUSE COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    THE CORRECTIONS ARE AS FOLLOWS: MEDICAL DEVICE TYPE: FMI. PMA / 510(K)#: K161170.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A SERIOUS INJURY OCCURRED WITH A BD ECLIPSE¿ NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "OCCURRED AT THE HOSPITAL, AN OCCUPATIONAL EXPOSURE WAS MANAGED WHEN A WARD STAFF MEMBER WAS ACTIVATING A SAFETY DEVICE & SUSTAINED A NEEDLESTICK."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A SERIOUS INJURY OCCURRED WITH A BD ECLIPSE¿ NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "OCCURRED AT THE HOSPITAL, AN OCCUPATIONAL EXPOSURE WAS MANAGED WHEN A WARD STAFF MEMBER WAS ACTIVATING A SAFETY DEVICE & SUSTAINED A NEEDLESTICK."

    Additional Manufacturer Narrative · 1

    (B)(4). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SERIOUS INJURY OCCURRED WITH A BD ECLIPSE¿ NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "OCCURRED AT THE HOSPITAL, AN OCCUPATIONAL EXPOSURE WAS MANAGED WHEN A WARD STAFF MEMBER WAS ACTIVATING A SAFETY DEVICE & SUSTAINED A NEEDLESTICK."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    416525 BD ECLIPSE¿ NEEDLE INSULIN SYRINGE FMI BECTON DICKINSON MEDICAL (SINGAPORE) 8148354 30382903057611

    Patients

    Seq Age Sex Outcome Treatment
    1 Other