BEUDAMED
    FDA Adverse Event Death Summary report: N

    BD VACUTAINER® EDTA 2K

    MDR report key: 7485402 · Received May 3, 2018

    Report

    Report Number
    1917413-2018-02629
    Event Type
    Death
    Date Received
    May 3, 2018
    Date of Event
    January 11, 2017
    Report Date
    June 15, 2018
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    JKA
    PMA / PMN Number
    K981013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE TYPE UPDATED TO (B)(6). THE 510(K)# UPDATED TO K981013:

    Additional Manufacturer Narrative · 1

    NO LOT # PROVIDED. DEVICE MANUFACTURE DATE: UNKNOWN. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. PMA / 510(K) #: THERE IS NO 510(K) GIVEN FOR THIS DEVICE . BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR EVALUATION; THEREFORE, THE INVESTIGATION WAS LIMITED. ADDITIONALLY, BD WAS UNABLE TO DETERMINE THE SPECIFIC LOT NUMBER ASSOCIATED WITH THIS COMPLAINT. THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD VACUTAINER® EDTA 2K DID NOT DRAW ENOUGH BLOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    325351 BD VACUTAINER® EDTA 2K BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other