BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® K2 EDTA (K2E) 5.4MG BLOOD COLLECTION TUBES

    MDR report key: 7491025 · Received May 7, 2018

    Report

    Report Number
    1917413-2018-01255
    Event Type
    Malfunction
    Date Received
    May 7, 2018
    Date of Event
    November 3, 2014
    Report Date
    June 1, 2018
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    JKA
    UDI-DI
    50382903678353
    PMA / PMN Number
    BK050036
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    MEDICAL DEVICE TYPE UPDATED TO JKA. UDI# UPDATED TO (B)(4). PMA/510(K)# UPDATED TO BK050036.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR EVALUATION; THEREFORE, THE INVESTIGATION WAS LIMITED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD VACUTAINER® K2 EDTA (K2E) 5.4MG BLOOD COLLECTION TUBES EXPERIENCED ERRONEOUS RESULTS. NO REPORT OF SERIOUS INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335718 BD VACUTAINER® K2 EDTA (K2E) 5.4MG BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. 4156921 50382903678353

    Patients

    Seq Age Sex Outcome Treatment
    1 Other