BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BECTON DICKINSON AND COMPANY, USA 21G X 1 1/4

    MDR report key: 10406951 · Received August 14, 2020

    Report

    Report Number
    10406951
    Event Type
    Injury
    Date Received
    August 14, 2020
    Date of Event
    July 29, 2020
    Report Date
    August 6, 2020
    Manufacturer
    BECTON, DICKINSON AND COMPANY
    Product Code
    FMI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    DE
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE SAFETY COVER ON TWO 21G X 1-1/4" (0.8 X 32 MM) BLOOD COLLECTION NEEDLES BROKE OFF. 5 DAYS LATER, THREE PINK SAFETY SHIELDS FROM BLOOD COLLECTION NEEDLES BROKE OFF. THEY CAME FROM A DIFFERENT BOX WITH A DIFFERENT LOT NUMBER (LOT #0030216) AND EXPIRATION DATE (EXP 01/31/2025) BROKE OFF. NO INJURIES TO PATIENTS OR HEALTHCARE PROVIDER OCCURRED IN EITHER INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    872430 BECTON DICKINSON AND COMPANY, USA 21G X 1 1/4 NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON, DICKINSON AND COMPANY 368607 0003865 / 0030216

    Patients

    Seq Age Sex Outcome Treatment
    1 Other