BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 12327979 · Received August 16, 2021

    Report

    Report Number
    1917413-2021-00738
    Event Type
    Malfunction
    Date Received
    August 16, 2021
    Date of Event
    July 22, 2021
    Report Date
    October 20, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    UDI-DI
    50382903678612
    PMA / PMN Number
    BK050036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR EVALUATION. THEREFORE, RETENTION SAMPLES OF THE INCIDENT LOT WERE SELECTED FROM BD INVENTORY FOR EVALUATION AND UPON COMPLETION, NO ISSUES RELATING TO MICROCLOTS WERE OBSERVED. 5 PRODUCTION LOT IN-HOUSE RETENTION SAMPLES FROM EACH LOT AFFECTED WERE VISUALLY INSPECTED WITH NO ISSUES BEING IDENTIFIED AND SUBMITTED TO THE CHEMISTRY LAB FOR TESTING. ALL RESULTS WERE WITHIN THE SPECIFICATION LIMITS OF 5.32MG ¿ 9.72MG FOR CATALOG 367861. NO DIFFICULTIES WERE ENCOUNTERED DURING BLOOD COLLECTION AND ALL TUBES APPEARED TO EXHIBIT PROPER FILL. BD WAS UNABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE (MICROCLOTS) BECAUSE THE DEFECT WAS NOT EVIDENT IN THE TESTING OF THE COMPLAINT LOT SAMPLES. LABORATORY ANALYSIS OF RETAIN AND CONTROL SAMPLES DEMONSTRATED CLINICALLY ACCEPTABLE PERFORMANCE FOR ALL VISUAL OBSERVATIONS EVALUATED. THE EDTA TUBES PERFORMED AS EXPECTED. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOT, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THERE WERE NO RELATED QUALITY ISSUES DURING MANUFACTURING OF THE PRODUCT. THIS COMPLAINT IS UNABLE TO BE CONFIRMED FOR THE INDICATED FAILURE MODE MICROCLOTS. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® K2 EDTA (K2E) 7.2MG BLOOD COLLECTION TUBES THERE WAS CLOTTING/MICRO CLOTS/FIBRIN CLOTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "WE ARE EXPERIENCING CLOTTING WITH THE PRODUCT."

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1040950, MEDICAL DEVICE EXPIRATION DATE: 2022-06-30, DEVICE MANUFACTURE DATE: 2021-02-09. MEDICAL DEVICE LOT #: 0316362. MEDICAL DEVICE EXPIRATION DATE: 2022-03-31. DEVICE MANUFACTURE DATE: 2020-11-11. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® K2 EDTA (K2E) 7.2MG BLOOD COLLECTION TUBES THERE WAS CLOTTING/MICRO CLOTS/FIBRIN CLOTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "WE ARE EXPERIENCING CLOTTING WITH THE PRODUCT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1225821 BD VACUTAINER® K2 EDTA (K2E) 7.2MG BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) 367861 SEE H.10 50382903678612

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown