BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETY-LOK BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER

    MDR report key: 3842800 · Received May 9, 2014

    Report

    Report Number
    3842800
    Event Type
    Malfunction
    Date Received
    May 9, 2014
    Date of Event
    April 14, 2014
    Report Date
    April 15, 2014
    Manufacturer
    BD - BECTON, DICKINSON AND COMPANY
    Product Code
    JKA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    LA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    BD SAFETY LOK BLOOD COLLECTION SET - NEEDLE WAS UNCAPPED IN TWO SEPARATE PACKAGE SETS. THE LOT NUMBER KNOWN FOR ONE OF THE TWO IS LOT#3275546. NO HARM OCCURRED TO STAFF MEMBERS OPENING PACKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281141 BD SAFETY-LOK BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION JKA BD - BECTON, DICKINSON AND COMPANY * 3275546

    Patients

    Seq Age Sex Outcome Treatment
    1 *