BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® K2 EDTA (K2E) 7.2MG BLOOD COLLECTION TUBES

    MDR report key: 7485419 · Received May 3, 2018

    Report

    Report Number
    1917413-2018-01241
    Event Type
    Malfunction
    Date Received
    May 3, 2018
    Date of Event
    January 3, 2017
    Report Date
    April 26, 2018
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    JKA
    UDI-DI
    50382903678612
    PMA / PMN Number
    BK050036
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    "MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 6253709; MEDICAL DEVICE EXPIRATION DATE:01/31/2018; DEVICE MANUFACTURE DATE: 09/09/2016. MEDICAL DEVICE LOT #: 6253710; MEDICAL DEVICE EXPIRATION DATE:01/31/2018; DEVICE MANUFACTURE DATE: 09/09/2016. " RESULTS: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR EVALUATION; THEREFORE, THE INVESTIGATION WAS LIMITED. A REVIEW OF THE MANUFACTURING RECORDS WAS COMPLETED FOR THE INCIDENT LOT AND NO ISSUES WERE IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE BD VACUTAINER® K2 EDTA (K2E) 7.2MG BLOOD COLLECTION TUBES WERE HAVING ERRONEOUS RESULTS , NO REPORT OF MEDICAL INTERVENTIONS OR SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    325070 BD VACUTAINER® K2 EDTA (K2E) 7.2MG BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. 6253706 50382903678612

    Patients

    Seq Age Sex Outcome Treatment
    1 Other