BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ECLIPSE¿ BLOOD COLLECTION NEEDLE WITH LUER ADAPTER

    MDR report key: 7059594 · Received November 27, 2017

    Report

    Report Number
    1024879-2017-00403
    Event Type
    Malfunction
    Date Received
    November 27, 2017
    Date of Event
    January 24, 2016
    Report Date
    October 26, 2017
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    FMI
    UDI-DI
    50382903686075
    PMA / PMN Number
    K982541
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 5182959. FORTY SAMPLES RECEIVED FROM CUSTOMER. SAMPLES WERE EVALUATED FOR FUNCTIONALITY OF LOCKING MECHANISM. NO BREAKAGE OR FAILURE IN LOCKING PROCESS WAS IDENTIFIED. CONCLUSION: THE ROOT CAUSE OF THE INDICATED FAILURE MODE IS INDETERMINATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SAFETY SHIELD OF THE 21 G X 1.25 IN BD ECLIPSE¿ BLOOD COLLECTION NEEDLE WITH LUER ADAPTER WAS NOT ACTIVATING TO COVER THE NEEDLE AFTER THE VENIPUNCTURE. NO INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    839067 BD ECLIPSE¿ BLOOD COLLECTION NEEDLE WITH LUER ADAPTER SAFETY ENGINEERED SAMPLE NEEDLE FMI BECTON, DICKINSON & CO., (BD) 5182959 50382903686075

    Patients

    Seq Age Sex Outcome Treatment
    1 Other