BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER

    MDR report key: 930536 · Received October 16, 2007

    Report

    Report Number
    MW5004126
    Event Type
    Malfunction
    Date Received
    October 16, 2007
    Date of Event
    October 10, 2007
    Report Date
    October 16, 2007
    Manufacturer
    BECTON DICKINSON
    Product Code
    JKA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    SAFETY NEEDLE MANUFACTURED BY BECTON DICKINSON UNDER THE PRODUCT NAME ECLIPSE MULTI-SAMPLE SAFETY BLOOD COLLECTION NEEDLE DEMONSTRATED 10 FAULTY SAFETY NEEDLE COVERS. THE PINK SAFETY CAP THAT CLIPS OVER THE NEEDLE AFTER USE BROKE OFF WHEN PHLEBOTOMIST WAS TRYING TO ENGAGE IT CLOSED. SUSPECTED LOT NUMBERS INCLUDE BOTH 21 GAUGE AND 22 GAUGE MULTI-SAMPLE ECLIPSE NEEDLES UNDER THE FOLLOWING LOT NUMBERS: 22 GAUGE LOT# 7124730 WITH EXPIRATION DATE OF 4/2012, AND 21 GAUGE LOT #7124997 -EXP: 4/2012 AND LOT #7151612 -EXP: 5/2012-. ONE NEEDLE STICK INJURY HAS ALREADY RESULTED FROM THIS DEFECT. EVENT ABATED AFTER USE STOPPED: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD VACUTAINER ECLIPSE BLOOD COLLECTION NEEDLE JKA BECTON DICKINSON 368607-21G- 7124730-22G
    2 BD VACUTAINER ECLIPSE BLOOD COLLECTION NEEDLE JKA BECTON DICKINSON 7124997-21G
    3 BD VACUTAINER ECLIPSE BLOOD COLLECTION NEEDLE JKA BECTON DICKINSON 7151612

    Patients

    Seq Age Sex Outcome Treatment
    1 YR