BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICROTAINER® TUBES WITH K2E (K2EDTA)

    MDR report key: 15551047 · Received October 6, 2022

    Report

    Report Number
    2618282-2022-00060
    Event Type
    Malfunction
    Date Received
    October 6, 2022
    Date of Event
    September 12, 2022
    Report Date
    October 31, 2022
    Manufacturer
    BD CARIBE LTD.
    Product Code
    JKA
    UDI-DI
    50382903659741
    PMA / PMN Number
    K991702
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 2038765. MEDICAL DEVICE EXPIRATION DATE: 2023-07-31. DEVICE MANUFACTURE DATE: 2022-02-07. MEDICAL DEVICE LOT #:1180595. MEDICAL DEVICE EXPIRATION DATE: 2022-12-31. DEVICE MANUFACTURE DATE: 2021-06-29. MEDICAL DEVICE LOT #: 2074144. MEDICAL DEVICE EXPIRATION DATE: 2023-08-31. DEVICE MANUFACTURE DATE: 2022-03-15.

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY: MATERIAL #: 365974. LOT/BATCH #: 2038765, 1180595, 2074144. BD HAD NOT RECEIVED SAMPLES, BUT 1 PHOTO WAS PROVIDED FOR INVESTIGATION. THE PHOTO WAS REVIEWED AND THE INDICATED FAILURE MODE FOR CLOTTING WAS NOT OBSERVED. FIFTY (50) RETENTION SAMPLES FROM EACH LOT WERE VISUALLY EVALUATED WITH ACCEPTABLE RESULTS. FIFTEEN (15) RESERVOIRS WERE TESTED PER EACH LOT (2038765, 1180595 AND 2074144) AT THE JUNCOS LABORATORY FOR K2 EDTA CONTENT AND NO SAMPLE HAD K2 EDTA ADDITIVE CONCENTRATION VALUES BELOW SPECIFICATION. ADDITIONALLY, RETENTION SAMPLES OF THE INCIDENT LOT WERE SELECTED FROM BD INVENTORY FOR EVALUATION AND UPON COMPLETION, NO ISSUES RELATING TO CLOTTING WERE OBSERVED. BD WAS UNABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE, CLOTTING BECAUSE THE DEFECT WAS NOT EVIDENT IN THE TESTING OF THE COMPLAINT LOT SAMPLES. VISUAL EVALUATIONS OF BOTH COMPLAINT LOT (RETAINS) AND CONTROL SAMPLES DEMONSTRATED CLINICALLY ACCEPTABLE PERFORMANCE FOR ALL VISUAL OBSERVATIONS EVALUATED. LABORATORY EVALUATION OF SAMPLES INDICATED THAT THESE TUBES PERFORMED AS EXPECTED. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOTS, 1180595 AND 2074144, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THERE WERE NO RELATED QUALITY ISSUES DURING MANUFACTURING OF THE PRODUCT. THE DEVICE HISTORY REVIEW FOR BATCH 2038765 WAS SATISFACTORY AT TIME OF RELEASE PER INTERNAL PROCEDURES. DURING MANUFACTURING/INSPECTION, THREE MACHINE NOZZLE POSITIONS WERE FOUND BELOW SPECIFICATION DEFECTS WERE OBSERVED. A QUALITY NOTIFICATION WAS GENERATED AND AFFECTED PRODUCTION WAS IDENTIFIED, SORTED BY MACHINE POSITION, AND SCRAPPED TO MITIGATE THE RISK OF THE DEFECT TO END-USER. THIS COMPLAINT IS UNABLE TO BE CONFIRMED FOR THE INDICATED FAILURE MODE CLOTTING. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. FACTORS THAT MAY CONTRIBUTE TO CLOTTING WERE EVALUATED THROUGH A CLINICAL STUDY TO VERIFY THE DESIGN OF THE DEVICE MET IT¿S INTENDED USE. THE RESULT OF THE STUDY SHOWED THAT THE DEVICE PERFORMED AS EXPECTED AND WE WERE UNABLE TO DETERMINE ANY EXTERNAL CONTRIBUTOR TO THIS REPORTED ISSUE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD MICROTAINER® TUBES WITH K2E (K2EDTA) THE SAMPLES CLOTTED. THIS EVENT OCCURRED 6 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "CUSTOMER PROBLEM: CUSTOMER IS REPORTING 6 CLOTTED SAMPLES FROM PRODUCT 365974 AND 4 WERE ASSOCIATED WITH LOT #2038765 WHILE THE OTHER 2 WERE FROM LOT# 1180595 AND 2074144."

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD MICROTAINER® TUBES WITH K2E (K2EDTA) THE SAMPLES CLOTTED. THIS EVENT OCCURRED 6 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "CUSTOMER PROBLEM: CUSTOMER IS REPORTING 6 CLOTTED SAMPLES FROM PRODUCT 365974 AND 4 WERE ASSOCIATED WITH LOT #2038765 WHILE THE OTHER 2 WERE FROM LOT# 1180595 AND 2074144.".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2898176 BD MICROTAINER® TUBES WITH K2E (K2EDTA) BLOOD SPECIMEN COLLECTION DEVICE JKA BD CARIBE LTD. 365974 2074144 50382903659741

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown