BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER K2E 7.2MG PLUS BLOOD COLLECTION TUBES

    MDR report key: 10544046 · Received September 16, 2020

    Report

    Report Number
    9617032-2020-00728
    Event Type
    Malfunction
    Date Received
    September 16, 2020
    Date of Event
    August 26, 2020
    Report Date
    February 17, 2021
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FOR EVALUATION. THEREFORE, (B)(4) RETENTION SAMPLES OF THE INCIDENT LOT WERE SELECTED FROM BD INVENTORY FOR EVALUATION AND UPON COMPLETION, NO ISSUES RELATING TO ERRONEOUS RESULTS WERE OBSERVED. (B)(4) RETAINED TUBES WERE ANALYZED FOR THE EDTA CONTENT FROM 2 BATCHES 0112585/0062294 AND WERE ALL WITHIN SPEC LIMITS AND (B)(4) RETAINED SAMPLES DRAW TESTED FROM BOTH BATCHES MENTIONED ABOVE THESE WERE ALSO WITH IN THE SPECIFICATION LIMITS. THE CUSTOMER HAS INDICATED THAT THE REPORTED CONDITION WAS NOTED IN SIGNIFICANTLY UNDERFILLED EDTA TUBES ("SUB OPTIMALLY FILLED"). THIS IS CONSIDERED AN OFF LABEL USE OF THIS PRODUCT AND WE RECOMMEND THAT THIS PRODUCT BE FILLED TO THE STATED FILL VOLUME TO ASSURE THE PROPER BLOOD TO ANTICOAGULANT RATIO. BD WILL CONTINUE TO MONITOR FOR ADDITIONAL COMPLAINTS AND EMERGING TRENDS. 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 NON-CONFORMANCES DURING MANUFACTURING OF THE PRODUCT.

    Description of Event or Problem · 0

    IT WAS REPORTED DURING USE THE BD VACUTAINER® K2E 7.2MG PLUS BLOOD COLLECTION TUBES EXPERIENCED ERRONEOUS RESULTS. THIS EVENT OCCURRED WITH 4 TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER STATED "A SMALL NUMBER OF EDTA SAMPLE TUBES HAVE BEEN GIVING IMPEDANCE PLATELET COUNTS THAT ARE INCONSISTENT WITH PREVIOUS COUNTS. TYPICALLY A PATIENT KNOWN TO RUN A PLATELET COUNT OF 150-200 WILL GIVE 400-600. IF THE ANALYSIS IS REPEATED ADDING IN AN OPTICAL PLATELET COUNT THE OPTICAL PLATELET COUNT WILL BE CONSISTENT WITH HISTORICAL RESULTS WHEREBY THE REPEAT IMPEDANCE COUNT WILL REMAIN INCORRECTLY HIGH. THIS PATTERN IS REPRODUCIBLE ACROSS DIFFERENT ANALYSERS. MOST OF THE SAMPLES WE HAVE SEEN GIVING THIS ERROR HAVE BEEN SUB OPTIMALLY FILLED"

    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 #: 0062294, MEDICAL DEVICE EXPIRATION DATE: 2021-06-30, DEVICE MANUFACTURE DATE: 2020-03-02, MEDICAL DEVICE LOT #: 0112585, MEDICAL DEVICE EXPIRATION DATE: 2021-08-31, DEVICE MANUFACTURE DATE: 2020-04-21. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED DURING USE THE BD VACUTAINER® K2E 7.2MG PLUS BLOOD COLLECTION TUBES EXPERIENCED ERRONEOUS RESULTS. THIS EVENT OCCURRED WITH 4 TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER STATED "A SMALL NUMBER OF EDTA SAMPLE TUBES HAVE BEEN GIVING IMPEDANCE PLATELET COUNTS THAT ARE INCONSISTENT WITH PREVIOUS COUNTS. TYPICALLY A PATIENT KNOWN TO RUN A PLATELET COUNT OF 150-200 WILL GIVE 400-600. IF THE ANALYSIS IS REPEATED ADDING IN AN OPTICAL PLATELET COUNT THE OPTICAL PLATELET COUNT WILL BE CONSISTENT WITH HISTORICAL RESULTS WHEREBY THE REPEAT IMPEDANCE COUNT WILL REMAIN INCORRECTLY HIGH. THIS PATTERN IS REPRODUCIBLE ACROSS DIFFERENT ANALYSERS. MOST OF THE SAMPLES WE HAVE SEEN GIVING THIS ERROR HAVE BEEN SUB OPTIMALLY FILLED".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1008988 BD VACUTAINER K2E 7.2MG PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other