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: 5657780 · Received May 16, 2016

    Report

    Report Number
    1024879-2016-00023
    Event Type
    Injury
    Date Received
    May 16, 2016
    Date of Event
    April 27, 2016
    Report Date
    May 24, 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
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: RESULT - A SAMPLE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO ABNORMALITIES DURING THE MANUFACTURE OF THE REPORTED LOT NUMBER 5182829. CONCLUSIONS - BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE AS THERE WAS SAMPLES RETURNED FOR EVALUATION. AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT HEALTHCARE PRACTITIONER (HCP) WAS TAKING BLOOD FROM A PATIENT USING THE SUSPECT DEVICE WHEN THE PINK SAFETY SHIELD SLIPPED TO THE SIDE. THE NEEDLE GRAZED THE MIDDLE FINGER OF HER LEFT HAND, CAUSING BLEEDING. THE HCP FOLLOWED THE FACILITY'S PROTOCOL AND BLED, WASHED, AND COVERED THE WOUND. A RISK ASSESSMENT WAS COMPLETED BY OCCUPATION HEALTH AND BLOOD WAS TAKEN FROM THE HCP, WHICH WAS SENT TO THE LAB FOR "SPIN & SAVE" PER PROTOCOL. NO PROPHYLACTIC MEDICATION WERE GIVEN. AS THE NECESSARY SCREENING WAS ALREADY BEING CARRIED OUT ON THE PATIENT AS PLANNED, NO ADDITIONAL LAB WORK WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312676 21 G X 1.25 IN. BD ECLIPSE¿ BLOOD COLLECTION NEEDLE WITH LUER ADAPTER SAMPLE NEEDLE FMI BECTON, DICKINSON & CO., (BD) 5182829

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention