BEUDAMED
    FDA Adverse Event Injury Summary report: N

    22 G X 1 IN. BD ECLIPSE¿ NEEDLE

    MDR report key: 6616571 · Received June 6, 2017

    Report

    Report Number
    8041187-2017-00049
    Event Type
    Injury
    Date Received
    June 6, 2017
    Date of Event
    May 16, 2017
    Report Date
    July 7, 2017
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FMI
    PMA / PMN Number
    K161170
    Removal / Correction Number
    MSS-16-837-FA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A SAMPLE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED AS A LOT NUMBER WAS NOT PROVIDED FOR THIS INCIDENT. WITHOUT A SAMPLE, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED AS BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE. CAPAS (B)(4) WERE OPENED TO IDENTIFY AND ADDRESS THE POTENTIAL CAUSES OF SAFETY SHIELD DISENGAGEMENT. REMEDIAL ACTION REQUIRED: FIELD ACTION NOTIFICATION MSS-16-837-FA WAS INITIATED AND A PRODUCT ADVISORY LETTER WAS SENT ON 12/29/2016.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A STUDENT NURSE GAVE AN INJECTION WITH A 22 G X 1 IN. BD ECLIPSE¿ NEEDLE BUT DID NOT HEAR THE CLICK OF THE SAFETY SHIELD UPON ACTIVATION. THE STUDENT NURSE DID NOT VISUALLY CONFIRM THE NEEDLE WAS COVERED AND THEN PROCEEDED TO RUN HER FINGER ALONG THE UNPROTECTED NEEDLE AND SUFFERED A CONTAMINATED NEEDLE STICK INJURY. THE STUDENT NURSE WAS EVALUATED IN AN EMERGENCY DEPARTMENT BUT IT IS UNKNOWN IF SHE WAS PROVIDED WITH ANY SPECIFIC MEDICAL INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396912 22 G X 1 IN. BD ECLIPSE¿ NEEDLE SAFETY ENGINEERED HYPODERMIC NEEDLE FMI BECTON DICKINSON MEDICAL (SINGAPORE) UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other