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: 5931262 · Received September 6, 2016

    Report

    Report Number
    1024879-2016-00035
    Event Type
    Injury
    Date Received
    September 6, 2016
    Date of Event
    August 19, 2016
    Report Date
    October 6, 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

    SAMPLES ARE AVAILABLE FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    RESULTS: FIVE UNUSED SAMPLES WERE RECEIVED FOR EVALUATION ALONG WITH A PHOTO OF THE USED DEVICE. EACH SAMPLE WAS HAND ACTIVATED TO EVALUATE DEVICE BREAKAGE. THE SAFETY SHIELD WAS ROTATED BACKWARD WITH EASE. THE SAFETY SHIELD WAS THEN ENGAGED OVER THE IV NEEDLE. THE LOCK-OUT FEATURES ENGAGED APPROPRIATELY AND NO BREAKAGE OF THE UNIT WAS IDENTIFIED. A PHOTO INSPECTION OF THE USED DEVICE REVEALED THE CUSTOMER'S REPORTED DEFECT (THE NEEDLE BROKE AT THE POINT WHERE THE NEEDLE SCREWS INTO THE VACUTAINER HOLDER). A REVIEW OF THE DEVICE HISTORY RECORD REVEALED THAT THE DEVICE WAS MANUFACTURED IN APRIL, 2016 AND NO IRREGULARITIES WERE FOUND DURING THE MANUFACTURE OF THE REPORTED LOT # 6091734. CONCLUSION: 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A 21 G X 1.25 IN. BD ECLIPSE BLOOD COLLECTION NEEDLE WITH LUER ADAPTER WAS USED TO DRAW A PATIENT'S BLOOD. THE NEEDLE BROKE AT THE POINT WHERE THE NEEDLE SCREWS INTO THE VACUTAINER HOLDER AND A CLINICIAN OBTAINED A CONTAMINATED NEEDLE STICK INJURY. THE CLINICIAN RECEIVED POST EXPOSURE LAB WORK FOR (B)(6) AND WILL BE ACTIVELY FOLLOWED BY EMPLOYEE HEALTH FOR NINE MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581716 21 G X 1.25 IN. BD ECLIPSE¿ BLOOD COLLECTION NEEDLE WITH LUER ADAPTER SAMPLE NEEDLE FMI BECTON, DICKINSON & CO., (BD) 6091734

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention