BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD ECLIPSE¿ NEEDLE

    MDR report key: 7096130 · Received December 7, 2017

    Report

    Report Number
    8041187-2017-00258
    Event Type
    Injury
    Date Received
    December 7, 2017
    Date of Event
    November 9, 2017
    Report Date
    November 29, 2017
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FMI
    UDI-DI
    30382903057666
    PMA / PMN Number
    K161170
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE LOT #: UNKNOWN. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. INVESTIGATION:  A SAMPLE IS NOT AVAILABLE FOR EVALUATION. CAPAS (B)(4) WERE OPENED TO IDENTIFY AND ADDRESS THE POTENTIAL CAUSES OF SAFETY SHIELD DISENGAGEMENT. ADDITIONALLY, FIELD ACTION NOTIFICATION MSS-16-837-FA WAS INITIATED AND A PRODUCT ADVISORY LETTER WAS SENT ON 12/29/2016.

    Description of Event or Problem · 1

    WHEN USING ABD ECLIPSE¿ NEEDLE IT WAS REPORTED THAT THE CUSTOMER WENT TO ENGAGE THE SAFETY AGAINST THE BED POINTING AWAY. IT DID NOT ENGAGE AND PRESSED HARDER, WHICH MADE THE NEEDLE BEND UP AND POKE THEM IN THE INDEX FINGER WHICH WAS IN THE AIR. CUSTOMER WAS HOLDING THE SYRINGE WITH THUMB AND MIDDLE FINGER. MEDICAL INTERVENTION WAS REPORTED AS ¿FIRST AID AND SERIAL LABS FOR BLOOD BORNE INFECTIONS.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    876015 BD ECLIPSE¿ NEEDLE SAFETY ENGINEERED HYPODERMIC NEEDLE FMI BECTON DICKINSON MEDICAL (SINGAPORE) UNKNOWN 30382903057666

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention