BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SODIUM FLUORIDE: 3 MG. NA2 EDTA: 6MG

    MDR report key: 8429467 · Received March 18, 2019

    Report

    Report Number
    1917413-2019-01009
    Event Type
    Malfunction
    Date Received
    March 18, 2019
    Date of Event
    February 28, 2019
    Report Date
    April 16, 2019
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    UDI-DI
    50382903675871
    PMA / PMN Number
    K945952
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELD WAS UPDATED DUE TO CORRECTED INFORMATION: DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT THE BD VACUTAINER® SODIUM FLUORIDE: 3 MG. NA2 EDTA: 6MG TUBE FORMED BUBBLES ON THE PLASMA SURFACE AFTER CENTRIFUGATION. TESTS WERE REPORTEDLY REDONE AS A RESULT OF THE MALFUNCTION. LOT #'S 8121553 AND 7340866 WERE REPORTED TO HAVE BEEN INVOLVED IN THIS EVENT, BUT IT IS UNKNOWN HOW MANY OCCURRENCES HAPPENED WITHIN EACH LOT. AS REPORTED BY THE CUSTOMER, "CUSTOMER INFORMS THAT THE EXAMS COLLECTED IN THE FLUORIDE TUBE NEED TO BE REPEATED AND ALL HAVE BUBBLES. REPORTED THAT AFTER THE CENTRIFUGATION, BUBBLES FORM ON THE SURFACE OF THE PLASMA. DUE TO WHAT HAPPENED THEY ARE REPEATING THE TESTS DONE. THERE WAS NO RELEASE OF ERRONEOUS RESULTS. (PHONE CONTACT ON (B)(6) 2019 AT 12:35 PM)" INVESTIGATION: INVESTIGATION SUMMARY: BD RECEIVED SAMPLES FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE SAMPLES WERE EVALUATED AND FOUND TO CONTAIN SUFFICIENT ADDITIVE. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR THE INCIDENT LOTS AND, BASED ON THIS REVIEW, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET; THERE WERE NO RELATED QUALITY NON-CONFORMANCES DURING MANUFACTURING OF THE PRODUCT. INVESTIGATION CONCLUSION: BASED ON EVALUATION OF THE CUSTOMER SAMPLES, THE CUSTOMER¿S INDICATED FAILURE MODE WITH THE INCIDENT LOT WAS NOT OBSERVED AS ALL SAMPLES MET THE REQUIRED SPECIFICATIONS. ROOT CAUSE DESCRIPTION: BASED ON THE INVESTIGATION, A ROOT CAUSE COULD NOT BE DETERMINED. THE PRODUCT WAS FOUND TO BE IN CONFORMANCE AND MEET RELEASE SPECIFICATIONS. RATIONALE: COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. THE BD BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD VACUTAINER® SODIUM FLUORIDE: 3 MG. NA2 EDTA: 6MG TUBE FORMED BUBBLES ON THE PLASMA SURFACE AFTER CENTRIFUGATION. TESTS WERE REPORTEDLY REDONE AS A RESULT OF THE MALFUNCTION. LOT #'S 8121553 AND 7340866 WERE REPORTED TO HAVE BEEN INVOLVED IN THIS EVENT, BUT IT IS UNKNOWN HOW MANY OCCURRENCES HAPPENED WITHIN EACH LOT. AS REPORTED BY THE CUSTOMER, "CUSTOMER INFORMS THAT THE EXAMS COLLECTED IN THE FLUORIDE TUBE NEED TO BE REPEATED AND ALL HAVE BUBBLES. REPORTED THAT AFTER THE CENTRIFUGATION, BUBBLES FORM ON THE SURFACE OF THE PLASMA. DUE TO WHAT HAPPENED THEY ARE REPEATING THE TESTS DONE. THERE WAS NO RELEASE OF ERRONEOUS RESULTS. (PHONE CONTACT ON (B)(6) 2019 AT 12:35 PM)".

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INITIAL REPORTER PHONE#: (B)(6). THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 8121553. MEDICAL DEVICE EXPIRATION DATE: 2019-09-30. DEVICE MANUFACTURE DATE: 2018-05-01. MEDICAL DEVICE LOT #: 7340866. MEDICAL DEVICE EXPIRATION DATE: 2019-04-30. DEVICE MANUFACTURE DATE: 2017-12-06. 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 THAT THE BD VACUTAINER® SODIUM FLUORIDE: 3 MG. NA2 EDTA: 6MG TUBE FORMED BUBBLES ON THE PLASMA SURFACE AFTER CENTRIFUGATION. TESTS WERE REPORTEDLY REDONE AS A RESULT OF THE MALFUNCTION. LOT #'S 8121553 AND 7340866 WERE REPORTED TO HAVE BEEN INVOLVED IN THIS EVENT, BUT IT IS UNKNOWN HOW MANY OCCURRENCES HAPPENED WITHIN EACH LOT. AS REPORTED BY THE CUSTOMER, "CUSTOMER INFORMS THAT THE EXAMS COLLECTED IN THE FLUORIDE TUBE NEED TO BE REPEATED AND ALL HAVE BUBBLES. MS. (B)(6) REPORTED THAT AFTER THE CENTRIFUGATION, BUBBLES FORM ON THE SURFACE OF THE PLASMA. DUE TO WHAT HAPPENED THEY ARE REPEATING THE TESTS DONE. THERE WAS NO RELEASE OF ERRONEOUS RESULTS. (PHONE CONTACT ON (B)(6) 2019 AT 12:35 PM)".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224091 BD VACUTAINER® SODIUM FLUORIDE: 3 MG. NA2 EDTA: 6MG BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) SEE SECTION H.10. 50382903675871

    Patients

    Seq Age Sex Outcome Treatment
    1 Other