BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® K2 EDTA (K2E) 3.6MG BLOOD COLLECTION TUBES

    MDR report key: 7558179 · Received May 31, 2018

    Report

    Report Number
    1917413-2018-02265
    Event Type
    Malfunction
    Date Received
    May 31, 2018
    Date of Event
    November 13, 2017
    Report Date
    May 7, 2018
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    GIM
    UDI-DI
    50382903678414
    PMA / PMN Number
    K981013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 #: 7180939. MEDICAL DEVICE EXPIRATION DATE: 10/31/2018. DEVICE MANUFACTURE DATE: 06/29/2017. MEDICAL DEVICE LOT #: 7157761. MEDICAL DEVICE EXPIRATION DATE: 09/30/2018. DEVICE MANUFACTURE DATE: 06/06/2017. BD RECEIVED SAMPLES FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE SAMPLES WERE EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE WITH THE INCIDENT LOT WAS NOT OBSERVED. 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 THAT BD VACUTAINER® K2 EDTA (K2E) 3.6MG BLOOD COLLECTION TUBES HAD UNDERFILL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398189 BD VACUTAINER® K2 EDTA (K2E) 3.6MG BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE GIM BECTON, DICKINSON & CO. 7157763 50382903678414

    Patients

    Seq Age Sex Outcome Treatment
    1 Other