BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE

    MDR report key: 7059629 · Received November 27, 2017

    Report

    Report Number
    1024879-2017-00668
    Event Type
    Malfunction
    Date Received
    November 27, 2017
    Date of Event
    December 4, 2015
    Report Date
    October 27, 2017
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    FMI
    UDI-DI
    50382903686082
    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

    RESULTS: FOUR REPRESENTATIVE SAMPLES WERE RETURNED FOR EVALUATION. ALL FOUR SAMPLES WERE EVALUATED FOR DEFECTIVE LOCKING OF THE SAFETY SHIELD WITH NO DEFECTS IDENTIFIED. A REVIEW OF THE DEVICE HISTORY RECORDS REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOTS # 5200974 AND 5128595. 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 THE SAFETY SHIELDS OF BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE, 22 G X 1.25 IN WOULD FLY OFF WHEN PREPARING THE NEEDS FOR USE. NO INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    841374 BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE SAFETY ENGINEERED SAMPLE NEEDLE FMI BECTON, DICKINSON & CO., (BD) 5200974 50382903686082

    Patients

    Seq Age Sex Outcome Treatment
    1 Other