BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® BLOOD ALCOHOL DETERMINATIONS SODIUM FLUORIDE TUBES

    MDR report key: 8722087 · Received June 21, 2019

    Report

    Report Number
    1917413-2019-01618
    Event Type
    Malfunction
    Date Received
    June 21, 2019
    Date of Event
    June 5, 2019
    Report Date
    July 22, 2019
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    UDI-DI
    50382903670012
    PMA / PMN Number
    K901449
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES, BUT PHOTOS WERE PROVIDED BY THE CUSTOMER FACILITY FOR INVESTIGATION. THE PHOTOS WERE EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE FOR ERRONEOUS RESULTS WITH THE INCIDENT LOTS COULD NOT BE OBSERVED. 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. SEVERAL OF THE INCIDENT LOTS HAD EXCEEDED THE LABELED EXPIRATION DATE AT THE TIME THE COMPLAINT WAS RECEIVED. ADDITIONALLY, BD TECHNICAL SERVICES CONTACTED THE CUSTOMER TO PROVIDE TROUBLESHOOTING, AND ADVISED THE CUSTOMER THAT BD DOES NOT HAVE TESTING TO SUPPORT THE USE OF THIS TUBE WITH THC TESTING. INVESTIGATION CONCLUSION: BASED ON EVALUATION OF THE CUSTOMER PHOTOS, THE CUSTOMER¿S INDICATED FAILURE MODE FOR ERRONEOUS RESULTS WITH THE INCIDENT LOT WAS NOT OBSERVED. THE PHOTOS DID NOT IDENTIFY A SPECIFIC PRODUCT ISSUE. ROOT CAUSE DESCRIPTION: BASED ON THE INVESTIGATION, THE MOST LIKELY ROOT CAUSE WAS ATTRIBUTED TO THE CUSTOMER'S USE OF THE PRODUCT IN AN APPLICATION OUTSIDE OF BD'S INSTRUCTIONS FOR USE (IFU). 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 BD VACUTAINER® BLOOD ALCOHOL DETERMINATIONS SODIUM FLUORIDE TUBES WERE GIVING ERRONEOUS RESULTS. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 367001 BATCH NO. 7033565, 8011948, 7256824, 7157747, 1178335, 9278354, 0341814, 6279843. IT IS REPORTED THAT THE PROBLEM WITH THE TUBES IS THAT SOME ADDITIVE IN YOUR TUBE IS INTERFERING WITH OUR GC/MS ANALYSIS OF THE BLOOD. WE HAVE SEEN THE ARTIFACT PROBLEM WITH OUR THC METHOD WITH MULTIPLE LOT #'S OF GRAY VACUTAINERS. THESE INCLUDE THE FOLLOWING LOT #'S: 7033565, EXP. 2019-2-28; 8011948, EXP. 2020-01-31; 7256824, EXP. 2019-09-30; 7157747, EXP. 2019-06-30; 1178335, EXP. 2013-07. WE HAVE A FEW OTHER LOTS, BUT I AM NOT COMPLETELY SURE IF WE HAVE ANALYZED THESE OR NOT: 9278354, EXP. 2011-10; 0341814, EXP. 2012-12; 6279843, EXP. 2018-10-31. THE PROBLEM WITH THE TUBES IS THAT SOME ADDITIVE IN YOUR TUBE IS INTERFERING WITH OUR GC/MS ANALYSIS OF THE BLOOD. WE HAVE TESTED SEVERAL DIFFERENT LOTS OF YOUR TUBES FROM DIFFERENT PEOPLE. THE GRAY TOP TUBES CONSISTENTLY SEEM TO INTERFERE WITH OUR TESTING. THE GRAY TOP TUBES FROM ANOTHER MANUFACTURER DO NOT.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 7033565, MEDICAL DEVICE EXPIRATION DATE: 2019-02-28, DEVICE MANUFACTURE DATE: 2017-02-02. MEDICAL DEVICE LOT #: 8011948, MEDICAL DEVICE EXPIRATION DATE: 2020-01-31, DEVICE MANUFACTURE DATE: 2018-01-11. MEDICAL DEVICE LOT #: 7256824, MEDICAL DEVICE EXPIRATION DATE: 2019-09-30, DEVICE MANUFACTURE DATE: 2017-09-13. MEDICAL DEVICE LOT #: 7157747, MEDICAL DEVICE EXPIRATION DATE: 2019-06-30, DEVICE MANUFACTURE DATE: 2017-06-06. MEDICAL DEVICE LOT #: 1178335, MEDICAL DEVICE EXPIRATION DATE: 2013-07-31, DEVICE MANUFACTURE DATE: 2011-06-27. MEDICAL DEVICE LOT #: 9278354, MEDICAL DEVICE EXPIRATION DATE: 2011-10-31, DEVICE MANUFACTURE DATE: 2009-10-05. MEDICAL DEVICE LOT #: 0341814, MEDICAL DEVICE EXPIRATION DATE: 2012-12-31, DEVICE MANUFACTURE DATE: 2010-12-07. MEDICAL DEVICE LOT #: 6279843, MEDICAL DEVICE EXPIRATION DATE: 2018-10-31, DEVICE MANUFACTURE DATE: 2016-10-05. (B)(6). DEVICE EVALUATED BY MFR: A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD VACUTAINER® BLOOD ALCOHOL DETERMINATIONS SODIUM FLUORIDE TUBES WERE GIVING ERRONEOUS RESULTS. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 367001, BATCH NO. 7033565, 8011948, 7256824, 7157747, 1178335, 9278354, 0341814, 6279843. IT IS REPORTED THAT THE PROBLEM WITH THE TUBES IS THAT SOME ADDITIVE IN YOUR TUBE IS INTERFERING WITH OUR GC/MS ANALYSIS OF THE BLOOD. WE HAVE SEEN THE ARTIFACT PROBLEM WITH OUR THC METHOD WITH MULTIPLE LOT #'S OF GRAY VACUTAINERS. THESE INCLUDE THE FOLLOWING LOT #'S: 7033565, EXP. 2019-2-28, 8011948, EXP. 2020-01-31, 7256824, EXP. 2019-09-30, 7157747, EXP. 2019-06-30, 1178335, EXP. 2013-07. WE HAVE A FEW OTHER LOTS, BUT I AM NOT COMPLETELY SURE IF WE HAVE ANALYZED THESE OR NOT: 9278354, EXP. 2011-10, 0341814, EXP. 2012-12, 6279843, EXP. 2018-10-31. THE PROBLEM WITH THE TUBES IS THAT SOME ADDITIVE IN YOUR TUBE IS INTERFERING WITH OUR GC/MS ANALYSIS OF THE BLOOD. WE HAVE TESTED SEVERAL DIFFERENT LOTS OF YOUR TUBES FROM DIFFERENT PEOPLE. THE GRAY TOP TUBES CONSISTENTLY SEEM TO INTERFERE WITH OUR TESTING. THE GRAY TOP TUBES FROM ANOTHER MANUFACTURER DO NOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    518784 BD VACUTAINER® BLOOD ALCOHOL DETERMINATIONS SODIUM FLUORIDE TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) SEE H.10 50382903670012

    Patients

    Seq Age Sex Outcome Treatment
    1 Other