BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 10728421 · Received October 23, 2020

    Report

    Report Number
    1917413-2020-00998
    Event Type
    Malfunction
    Date Received
    October 23, 2020
    Date of Event
    October 3, 2020
    Report Date
    November 2, 2020
    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
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY : BD RECEIVED 84 SAMPLES FOR INVESTIGATION. NO PHOTOS WERE PROVIDED BY THE CUSTOMER FACILITY. THE INVESTIGATION FOR MATERIAL # 367861, LOT 0100274 WAS CONDUCTED UNDER (B)(6) AND INCLUDED RETURN MATERIAL FROM THE CUSTOMER. THE SAMPLES WERE EVALUATED VISUALLY, WITH NO ISSUES BEING IDENTIFIED. IN ADDITION, CUSTOMER SAMPLES WERE SENT TO THE CHEMISTRY LABORATORY FOR TITRATION TESTING. ALL TUBES MET SPECIFICATION REQUIREMENTS. 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. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. BD WAS UNABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE WITH THE CUSTOMER SAMPLES. BLOOD COLLECTION TUBES ARE DESIGNED TO DRAW THE APPROPRIATE VOLUME TO ENSURE A PROPER BLOOD TO ADDITIVE RATIO, NOT HAVING THE CORRECT BLOOD TO ADDITIVE RATIO CAN LEAD TO CLOTTING. ALSO, IN TUBES WITH ANTICOAGULANTS, INADEQUATE MIXING MAY RESULT IN PLATELET CLUMPING, CLOTTING AND/OR INCORRECT TEST RESULTS. IT IS RECOMMENDED THAT AN EDTA TUBE BE INVERTED 8-10 TIMES IMMEDIATELY AFTER THE SPECIMEN IS COLLECTED. NOT COMPLETING THESE INVERSIONS MAY RESULT IN INCOMPLETE MIXING OF THE ADDITIVE IN THE BLOOD, LEADING TO PLATELET CLUMPING, CLOTTING, AND INCORRECT TEST RESULTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER USE WITH A BD VACUTAINER® K2 EDTA (K2E) 7.2MG BLOOD COLLECTION TUBES MICRO CLOTTING OCCURRED. THE ERRONEOUS RESULTS WERE NOT REPORTED. THE PATIENT WAS RE-DRAWN AND MAY HAVE DELAYED CARE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (2 OF 18 COMPLAINTS) ONCE WE IDENTIFIED A PROBLEMATIC LOT, WE TESTED 16 HEALTHY EMPLOYEES. NONE OF THE TUBES HAD A MACROSCOPIC CLOT. WE WERE NOT ABLE TO OBTAIN A DIFFERENTIAL ON OUR CBC ANALYZERS AND THE HISTOGRAMS LOOKED HORRIBLE. 100% WERE AFFECTED. AS OF NOW, WE ARE NOT HAVING ANY ISSUES WITH TUBES FROM THE OTHER LOT NUMBERS. ADDITIONALLY, ON 2020-10-08 THE CUSTOMER PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: ERRONEOUS RESULTS WERE NOT REPORTED, BUT AT LEAST 100 SPECIMENS HAD TO BE RECOLLECTED OVER A PERIOD OF 2 DAYS UNTIL THE PROBLEM COULD BE IDENTIFIED AND THE LOT NUMBER COULD BE ISOLATED AND REMOVED FROM USE. THE SAMPLES WERE TESTED WITHIN 4 HOURS AND STORED AT ROOM TEMP. IN THE EXAMPLES WE PROVIDED ¿ ONLY EDTA TUBES WERE DRAWN. SYSMEX XE -9100 ANALYZER WAS USED TO TEST SPECIMEN. CALIBRATION WAS CHECKED BY A SERVICE ENGINEER IMMEDIATELY BEFORE THE SAMPLES WERE RUN ON (B)(6) 2020. THE EXMAPLES I SENT WERE FROM HEALTHLY VOLUNTEERS WHO WERE NOT REDRAWN. ERRONEOUS RESULTS WERE NOT REPORTED, HOWEVER TESTING WAS DELAYED BY AS MUCH AS 24 HOURS WHILE WE ATTEMPTED TO DETERMINE THE CAUSE OF THE PROBLEM. THE DELAYED RESULTS COULD HAVE IMPACTED PATIENT CARE.

    Additional Manufacturer Narrative · 1

    A SAMPLE IS AVAILABLE FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER USE WITH A BD VACUTAINER® K2 EDTA (K2E) 7.2MG BLOOD COLLECTION TUBES MICRO CLOTTING OCCURRED. THE ERRONEOUS RESULTS WERE NOT REPORTED. THE PATIENT WAS RE-DRAWN AND MAY HAVE DELAYED CARE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (2 OF 18 COMPLAINTS) ONCE WE IDENTIFIED A PROBLEMATIC LOT, WE TESTED 16 HEALTHY EMPLOYEES. NONE OF THE TUBES HAD A MACROSCOPIC CLOT. WE WERE NOT ABLE TO OBTAIN A DIFFERENTIAL ON OUR CBC ANALYZERS AND THE HISTOGRAMS LOOKED HORRIBLE. 100% WERE AFFECTED. AS OF NOW, WE ARE NOT HAVING ANY ISSUES WITH TUBES FROM THE OTHER LOT NUMBERS. ADDITIONALLY, ON 2020-10-08 THE CUSTOMER PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: ERRONEOUS RESULTS WERE NOT REPORTED, BUT AT LEAST 100 SPECIMENS HAD TO BE RECOLLECTED OVER A PERIOD OF 2 DAYS UNTIL THE PROBLEM COULD BE IDENTIFIED AND THE LOT NUMBER COULD BE ISOLATED AND REMOVED FROM USE. THE SAMPLES WERE TESTED WITHIN 4 HOURS AND STORED AT ROOM TEMP. IN THE EXAMPLES WE PROVIDED ¿ ONLY EDTA TUBES WERE DRAWN. SYSMEX XE -9100 ANALYZER WAS USED TO TEST SPECIMEN. CALIBRATION WAS CHECKED BY A SERVICE ENGINEER IMMEDIATELY BEFORE THE SAMPLES WERE RUN ON (B)(6) 2020. THE EXAMPLES I SENT WERE FROM HEALTHY VOLUNTEERS WHO WERE NOT REDRAWN. ERRONEOUS RESULTS WERE NOT REPORTED, HOWEVER TESTING WAS DELAYED BY AS MUCH AS 24 HOURS WHILE WE ATTEMPTED TO DETERMINE THE CAUSE OF THE PROBLEM. THE DELAYED RESULTS COULD HAVE IMPACTED PATIENT CARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1196014 BD VACUTAINER® K2 EDTA (K2E) 7.2MG BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) 367861 0100274 50382903678612

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown