BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    21 G X 1.25 IN BD ECLIPSE¿ BLOOD COLLECTION NEEDLE WITH LUER ADAPTER

    MDR report key: 7063991 · Received November 28, 2017

    Report

    Report Number
    1024879-2017-00311
    Event Type
    Malfunction
    Date Received
    November 28, 2017
    Date of Event
    May 20, 2016
    Report Date
    October 25, 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
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SAMPLE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT #6070998. A CUSTOMER PHOTO WAS RECEIVED WHICH SHOWS AN ECLIPSE WITH PRE-ATTACHED HOLDER WITH THE COLLAR SEPARATED FROM HUB. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 21 G X 1.25 IN BD ECLIPSE¿ BLOOD COLLECTION NEEDLE WITH LUER ADAPTER SAFETY SHIELD DISENGAGED WHEN SCREWING THE NEEDLE INTO THE NEEDLE HOLDER. NO INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    841741 21 G X 1.25 IN BD ECLIPSE¿ BLOOD COLLECTION NEEDLE WITH LUER ADAPTER SAFETY ENGINEERED SAMPLE NEEDLE FMI BECTON, DICKINSON & CO., (BD) 6070998 50382903686075

    Patients

    Seq Age Sex Outcome Treatment
    1 Other