BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE, 21 G X 1.25 IN.

    MDR report key: 7058700 · Received November 27, 2017

    Report

    Report Number
    1024879-2017-00681
    Event Type
    Malfunction
    Date Received
    November 27, 2017
    Date of Event
    April 28, 2016
    Report Date
    October 27, 2017
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    FMI
    UDI-DI
    00382903686094
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INITIAL REPORTER PHONE #: UNKNOWN. RESULTS: PHOTOGRAPH WAS RETURNED THAT SHOWED LEAKAGE. TEN CUSTOMER SAMPLES WERE RETURNED THAT SHOWED NO DEFECT. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT #5252587, 5203971, 6020623. SAMPLES AND PHOTOS WERE RETURNED FOR LOT NUMBERS: 5203971, 6020623. CONCLUSION: 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 BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE, 21 G X 1.25 IN. NEEDLE CAME LOOSE FROM HOLDER DURING USE WHICH RESULTED IN BLOOD LEAKAGE. ECLIPSE NEEDLE USED IN COMBINATION WITH PRONTO HOLDER. NO SERIOUS INJURY, BLOOD EXPOSURE OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    839046 BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE, 21 G X 1.25 IN. SAFETY ENGINEERED SAMPLE NEEDLE FMI BECTON, DICKINSON & CO., (BD) 5252587 00382903686094

    Patients

    Seq Age Sex Outcome Treatment
    1 Other