BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SODIUM FLUORIDE POTASSIUM OXALATE (FX) BLOOD COLLECTION TUBES

    MDR report key: 8480391 · Received April 3, 2019

    Report

    Report Number
    2243072-2019-00653
    Event Type
    Malfunction
    Date Received
    April 3, 2019
    Date of Event
    March 14, 2019
    Report Date
    July 26, 2019
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    PMA / PMN Number
    K901449
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTIONS: B.5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT BD VACUTAINER® SODIUM FLUORIDE POTASSIUM OXALATE (FX) BLOOD COLLECTION TUBES WERE GIVING ERRONEOUS RESULTS. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 367921 BATCH NO. UNKNOWN (PROVIDED 17340936). IT WAS REPORTED THAT RECENT INTERNAL CLINICAL STUDY HAS IDENTIFIED THAT THERE IS A POTENTIAL FOR A POSITIVE BIAS FOR BENZODIAZEPINES WHEN COMPARING THE BD VACUTAINER® FLUORIDE TUBE VS. THE GREINER NAF/KOX TUBE. AND FYI, THIS WAS AN EXTERNAL STUDY: A RECENT INTERNAL CLINICAL STUDY HAS IDENTIFIED THAT THERE IS A POTENTIAL FOR A POSITIVE BIAS FOR BENZODIAZEPINES WHEN COMPARING THE BD VACUTAINER® FLUORIDE TUBE VS. THE GREINER NAF/KOX TUBE. IN THE ASSESSMENT OF BENZODIAZEPINES, BD TUBES WITH STOPPERS MANUFACTURED WITH THIURAM COMPARED WITH BD TUBES WITH STOPPERS NOT MANUFACTURED WITH THIURAM DEMONSTRATED CLINICAL EQUIVALENCE. CLINICAL EQUIVALENCE WAS ALSO DEMONSTRATED IN THE COMPARISON OF BD SERUM TUBES WITH STOPPERS THAT WERE NOT MANUFACTURED WITH THIURAM TO OTHER NON-THIURAM BD AND COMPETITOR SERUM TUBES. IN BD TUBE COMPARISONS WITH GREINER (THIURAM VS COMPETITOR), FOUR OUT OF FIVE COMPARISONS DEMONSTRATED CLINICAL EQUIVALENCE. THE COMPARISON OF BD FLUORIDE VS GREINER NAF/KOX TUBES WAS CLINICALLY UNACCEPTABLE DUE TO A POSITIVE BIAS WHICH EXCEEDED THE CAL AT ONE OF THE MEDICALLY RELEVANT POINTS. THIS BIAS IS LIKELY DUE TO AN IMPACT FROM HEMOLYSIS IN THE BENZODIAZEPINE TEST METHOD USED IN THIS STUDY, WITH THE MAGNITUDE OF THE EFFECT GREATER WITH THE TUBE DEMONSTRATING THE GREATER OCCURRENCE OF HEMOLYSIS (GREINER), RESULTING IN LOWER VALUES FOR THIS TUBE. D.1. MEDICAL DEVICE BRAND NAME: BD VACUTAINER® SODIUM FLUORIDE POTASSIUM OXALATE (FX) BLOOD COLLECTION TUBES D.4. MEDICAL DEVICE CATALOG #: 367921, D.4. MEDICAL DEVICE LOT #: 17340936, D.4. UNIQUE IDENTIFIER (UDI) #: (B)(4), E.1. INITIAL REPORTER FIRST NAME: (B)(6), E.1. INITIAL REPORTER LAST NAME: (B)(6), E.1. INITIAL REPORTER PHONE#: (B)(6), E.1. INITIAL REPORTER EMAIL ADDRESS: (B)(6), G.5. PMA/510(K)#: K901449.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR EVALUATION; THEREFORE, THE INVESTIGATION WAS LIMITED. ADDITIONALLY, BD WAS UNABLE TO DETERMINE THE SPECIFIC LOT NUMBER ASSOCIATED WITH THIS COMPLAINT. THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED. INVESTIGATION CONCLUSION: AS NO SAMPLES OR PHOTOS WERE RECEIVED FOR EVALUATION, THE CUSTOMER'S INDICATED FAILURE MODE WAS NOT OBSERVED BY BD. ROOT CAUSE DESCRIPTION: AS THERE WAS NO SAMPLE OR PHOTO AVAILABLE FOR EVALUATION, A ROOT CAUSE COULD NOT BE DETERMINED. 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. H3 OTHER TEXT : SEE H.10.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTIONS: B.5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT BD VACUTAINER® SODIUM FLUORIDE POTASSIUM OXALATE (FX) BLOOD COLLECTION TUBES WAS GIVING ERRONEOUS RESULTS. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 367921 BATCH NO. UNKNOWN (PROVIDED 17340936) IT WAS REPORTED THAT RECENT INTERNAL CLINICAL STUDY HAS IDENTIFIED THAT THERE IS A POTENTIAL FOR A POSITIVE BIAS FOR BENZODIAZEPINES WHEN COMPARING THE BD VACUTAINER® FLUORIDE TUBE VS. THE GREINER NAF/KOX TUBE. **AND FYI, THIS WAS AN EXTERNAL STUDY** A RECENT INTERNAL CLINICAL STUDY HAS IDENTIFIED THAT THERE IS A POTENTIAL FOR A POSITIVE BIAS FOR BENZODIAZEPINES WHEN COMPARING THE BD VACUTAINER® FLUORIDE TUBE VS. THE GREINER NAF/KOX TUBE. IN THE ASSESSMENT OF BENZODIAZEPINES, BD TUBES WITH STOPPERS MANUFACTURED WITH THIURAM COMPARED WITH BD TUBES WITH STOPPERS NOT MANUFACTURED WITH THIURAM DEMONSTRATED CLINICAL EQUIVALENCE. CLINICAL EQUIVALENCE WAS ALSO DEMONSTRATED IN THE COMPARISON OF BD SERUM TUBES WITH STOPPERS THAT WERE NOT MANUFACTURED WITH THIURAM TO OTHER NON-THIURAM BD AND COMPETITOR SERUM TUBES. IN BD TUBE COMPARISONS WITH GREINER (THIURAM VS COMPETITOR), FOUR OUT OF FIVE COMPARISONS DEMONSTRATED CLINICAL EQUIVALENCE. THE COMPARISON OF BD FLUORIDE VS GREINER NAF/KOX TUBES WAS CLINICALLY UNACCEPTABLE DUE TO A POSITIVE BIAS WHICH EXCEEDED THE CAL AT ONE OF THE MEDICALLY RELEVANT POINTS. THIS BIAS IS LIKELY DUE TO AN IMPACT FROM HEMOLYSIS IN THE BENZODIAZEPINE TEST METHOD USED IN THIS STUDY, WITH THE MAGNITUDE OF THE EFFECT GREATER WITH THE TUBE DEMONSTRATING THE GREATER OCCURRENCE OF HEMOLYSIS (GREINER), RESULTING IN LOWER VALUES FOR THIS TUBE. D.3. MEDICAL DEVICE MANUFACTURER: BROKEN BOW. D.4. MEDICAL DEVICE LOT #: UNKNOWN. G.1. MANUFACTURING LOCATION: BROKEN BOW.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD VACUTAINER® SODIUM FLUORIDE POTASSIUM OXALATE (FX) BLOOD COLLECTION TUBES WERE GIVING ERRONEOUS RESULTS. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 367921 BATCH NO. UNKNOWN (PROVIDED 17340936). IT WAS REPORTED THAT RECENT INTERNAL CLINICAL STUDY HAS IDENTIFIED THAT THERE IS A POTENTIAL FOR A POSITIVE BIAS FOR BENZODIAZEPINES WHEN COMPARING THE BD VACUTAINER® FLUORIDE TUBE VS. THE GREINER NAF/KOX TUBE. AND FYI, THIS WAS AN EXTERNAL STUDY: A RECENT INTERNAL CLINICAL STUDY HAS IDENTIFIED THAT THERE IS A POTENTIAL FOR A POSITIVE BIAS FOR BENZODIAZEPINES WHEN COMPARING THE BD VACUTAINER® FLUORIDE TUBE VS. THE GREINER NAF/KOX TUBE. IN THE ASSESSMENT OF BENZODIAZEPINES, BD TUBES WITH STOPPERS MANUFACTURED WITH THIURAM COMPARED WITH BD TUBES WITH STOPPERS NOT MANUFACTURED WITH THIURAM DEMONSTRATED CLINICAL EQUIVALENCE. CLINICAL EQUIVALENCE WAS ALSO DEMONSTRATED IN THE COMPARISON OF BD SERUM TUBES WITH STOPPERS THAT WERE NOT MANUFACTURED WITH THIURAM TO OTHER NON-THIURAM BD AND COMPETITOR SERUM TUBES. IN BD TUBE COMPARISONS WITH GREINER (THIURAM VS COMPETITOR), FOUR OUT OF FIVE COMPARISONS DEMONSTRATED CLINICAL EQUIVALENCE. THE COMPARISON OF BD FLUORIDE VS GREINER NAF/KOX TUBES WAS CLINICALLY UNACCEPTABLE DUE TO A POSITIVE BIAS WHICH EXCEEDED THE CAL AT ONE OF THE MEDICALLY RELEVANT POINTS. THIS BIAS IS LIKELY DUE TO AN IMPACT FROM HEMOLYSIS IN THE BENZODIAZEPINE TEST METHOD USED IN THIS STUDY, WITH THE MAGNITUDE OF THE EFFECT GREATER WITH THE TUBE DEMONSTRATING THE GREATER OCCURRENCE OF HEMOLYSIS (GREINER), RESULTING IN LOWER VALUES FOR THIS TUBE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD VACUTAINER® SODIUM FLUORIDE POTASSIUM OXALATE (FX) BLOOD COLLECTION TUBES WAS GIVING ERRONEOUS RESULTS. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 367921; BATCH NO. UNKNOWN (PROVIDED: 17340936). IT WAS REPORTED THAT RECENT INTERNAL CLINICAL STUDY HAS IDENTIFIED THAT THERE IS A POTENTIAL FOR A POSITIVE BIAS FOR BENZODIAZEPINES WHEN COMPARING THE BD VACUTAINER® FLUORIDE TUBE VS. THE GREINER NAF/KOX TUBE. AND FYI, THIS WAS AN EXTERNAL STUDY: A RECENT INTERNAL CLINICAL STUDY HAS IDENTIFIED THAT THERE IS A POTENTIAL FOR A POSITIVE BIAS FOR BENZODIAZEPINES WHEN COMPARING THE BD VACUTAINER® FLUORIDE TUBE VS. THE GREINER NAF/KOX TUBE. IN THE ASSESSMENT OF BENZODIAZEPINES, BD TUBES WITH STOPPERS MANUFACTURED WITH THIURAM COMPARED WITH BD TUBES WITH STOPPERS NOT MANUFACTURED WITH THIURAM DEMONSTRATED CLINICAL EQUIVALENCE. CLINICAL EQUIVALENCE WAS ALSO DEMONSTRATED IN THE COMPARISON OF BD SERUM TUBES WITH STOPPERS THAT WERE NOT MANUFACTURED WITH THIURAM TO OTHER NON-THIURAM BD AND COMPETITOR SERUM TUBES. IN BD TUBE COMPARISONS WITH GREINER (THIURAM VS COMPETITOR), FOUR OUT OF FIVE COMPARISONS DEMONSTRATED CLINICAL EQUIVALENCE. THE COMPARISON OF BD FLUORIDE VS GREINER NAF/KOX TUBES WAS CLINICALLY UNACCEPTABLE DUE TO A POSITIVE BIAS WHICH EXCEEDED THE CAL AT ONE OF THE MEDICALLY RELEVANT POINTS. THIS BIAS IS LIKELY DUE TO AN IMPACT FROM HEMOLYSIS IN THE BENZODIAZEPINE TEST METHOD USED IN THIS STUDY, WITH THE MAGNITUDE OF THE EFFECT GREATER WITH THE TUBE DEMONSTRATING THE GREATER OCCURRENCE OF HEMOLYSIS (GREINER), RESULTING IN LOWER VALUES FOR THIS TUBE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD VACUTAINER® SODIUM FLUORIDE POTASSIUM OXALATE (FX) BLOOD COLLECTION TUBES WAS GIVING ERRONEOUS RESULTS. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 367921 BATCH NO. UNKNOWN (PROVIDED 17340936) IT WAS REPORTED THAT RECENT INTERNAL CLINICAL STUDY HAS IDENTIFIED THAT THERE IS A POTENTIAL FOR A POSITIVE BIAS FOR BENZODIAZEPINES WHEN COMPARING THE BD VACUTAINER® FLUORIDE TUBE VS. THE GREINER NAF/KOX TUBE. **AND FYI, THIS WAS AN EXTERNAL STUDY** A RECENT INTERNAL CLINICAL STUDY HAS IDENTIFIED THAT THERE IS A POTENTIAL FOR A POSITIVE BIAS FOR BENZODIAZEPINES WHEN COMPARING THE BD VACUTAINER® FLUORIDE TUBE VS. THE GREINER NAF/KOX TUBE. IN THE ASSESSMENT OF BENZODIAZEPINES, BD TUBES WITH STOPPERS MANUFACTURED WITH THIURAM COMPARED WITH BD TUBES WITH STOPPERS NOT MANUFACTURED WITH THIURAM DEMONSTRATED CLINICAL EQUIVALENCE. CLINICAL EQUIVALENCE WAS ALSO DEMONSTRATED IN THE COMPARISON OF BD SERUM TUBES WITH STOPPERS THAT WERE NOT MANUFACTURED WITH THIURAM TO OTHER NON-THIURAM BD AND COMPETITOR SERUM TUBES. IN BD TUBE COMPARISONS WITH GREINER (THIURAM VS COMPETITOR), FOUR OUT OF FIVE COMPARISONS DEMONSTRATED CLINICAL EQUIVALENCE. THE COMPARISON OF BD FLUORIDE VS GREINER NAF/KOX TUBES WAS CLINICALLY UNACCEPTABLE DUE TO A POSITIVE BIAS WHICH EXCEEDED THE CAL AT ONE OF THE MEDICALLY RELEVANT POINTS. THIS BIAS IS LIKELY DUE TO AN IMPACT FROM HEMOLYSIS IN THE BENZODIAZEPINE TEST METHOD USED IN THIS STUDY, WITH THE MAGNITUDE OF THE EFFECT GREATER WITH THE TUBE DEMONSTRATING THE GREATER OCCURRENCE OF HEMOLYSIS (GREINER), RESULTING IN LOWER VALUES FOR THIS TUBE.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. (B)(4). MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. INITIAL REPORTER FACILITY: THE USER FACILITY ADDRESS IS NOT AVAILABLE, THE CORPORATE HEADQUARTERS INFORMATION WAS USED INSTEAD. 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. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UNSPECIFIED BD¿ TUBE WAS GIVING ERRONEOUS RESULTS. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. UNKNOWN BATCH NO. UNKNOWN. IT WAS REPORTED THAT RECENT INTERNAL CLINICAL STUDY HAS IDENTIFIED THAT THERE IS A POTENTIAL FOR A POSITIVE BIAS FOR BENZODIAZEPINES WHEN COMPARING THE BD VACUTAINER® FLUORIDE TUBE VS. THE GREINER NAF/KOX TUBE. A RECENT INTERNAL CLINICAL STUDY HAS IDENTIFIED THAT THERE IS A POTENTIAL FOR A POSITIVE BIAS FOR BENZODIAZEPINES WHEN COMPARING THE BD VACUTAINER® FLUORIDE TUBE VS. THE GREINER NAF/KOX TUBE. IN THE ASSESSMENT OF BENZODIAZEPINES, BD TUBES WITH STOPPERS MANUFACTURED WITH THIURAM COMPARED WITH BD TUBES WITH STOPPERS NOT MANUFACTURED WITH THIURAM DEMONSTRATED CLINICAL EQUIVALENCE. CLINICAL EQUIVALENCE WAS ALSO DEMONSTRATED IN THE COMPARISON OF BD SERUM TUBES WITH STOPPERS THAT WERE NOT MANUFACTURED WITH THIURAM TO OTHER NON-THIURAM BD AND COMPETITOR SERUM TUBES. IN BD TUBE COMPARISONS WITH GREINER (THIURAM VS COMPETITOR), FOUR OUT OF FIVE COMPARISONS DEMONSTRATED CLINICAL EQUIVALENCE. THE COMPARISON OF BD FLUORIDE VS GREINER NAF/KOX TUBES WAS CLINICALLY UNACCEPTABLE DUE TO A POSITIVE BIAS WHICH EXCEEDED THE CAL AT ONE OF THE MEDICALLY RELEVANT POINTS. THIS BIAS IS LIKELY DUE TO AN IMPACT FROM HEMOLYSIS IN THE BENZODIAZEPINE TEST METHOD USED IN THIS STUDY, WITH THE MAGNITUDE OF THE EFFECT GREATER WITH THE TUBE DEMONSTRATING THE GREATER OCCURRENCE OF HEMOLYSIS (GREINER), RESULTING IN LOWER VALUES FOR THIS TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273516 BD VACUTAINER® SODIUM FLUORIDE POTASSIUM OXALATE (FX) BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other