BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ BLOOD COLLECTION TUBE

    MDR report key: 9355752 · Received November 21, 2019

    Report

    Report Number
    1024879-2019-02012
    Event Type
    Malfunction
    Date Received
    November 21, 2019
    Date of Event
    November 8, 2019
    Report Date
    February 21, 2020
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    50382903679862
    PMA / PMN Number
    BK050036
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR EVALUATION. BD ACKNOWLEDGES THE CUSTOMER'S EXPERIENCE REGARDING THE INDICATED FAILURE MODE FOR ERRONEOUS RESULTS WITH THE INCIDENT LOT. A REVIEW OF THE MANUFACTURING RECORDS WAS COMPLETED FOR THE INCIDENT LOT AND NO ISSUES WERE IDENTIFIED. BD HAS NO DATA FOR ANY BIOLOGIC DRUG ANALYSIS ON THIS PRODUCT. THE EVENT DESCRIBED BY THE CUSTOMER REGARDING EXTENDED FREEZE TIME AND SUBSEQUENT THAW FOR ANALYSIS MAY INDICATE A SAMPLE QUALITY ISSUE THAT MAY REQUIRE FURTHER SAMPLE CLARIFICATION (DECANTING AND RE-CENTRIFUGATION). POST CENTRIFUGATION: THE SPECIMEN IN THE ORIGINAL TUBE SHOULD BE CENTRIFUGED ONCE. TUBES SHOULD NOT BE RE-CENTRIFUGED ONCE THE BARRIER IS FORMED. A POTENTIAL FOR INACCURATE TEST RESULTS IS POSSIBLE. ANALYTES FROM CELLULAR LEAKAGE/EXCHANGE, ACCENTUATED BY CLOT RETRACTION, WILL THEN BE CENTRIFUGED INTO THE SERUM BEING USED FOR TESTING. IF RE-CENTRIFUGATION IS REQUIRED FOR IMPROVED SERUM QUALITY, THEN ASPIRATE SERUM INTO A PROPERLY LABELED CLEAN TUBE. ADHERENCE TO THE RECOMMENDED SPECIMEN HANDLING AND PROCESSING STEPS WILL FACILITATE ACCEPTABLE SPECIMEN QUALITY AND OVERALL PERFORMANCE FOR RELIABLE ANALYTICAL OUTCOMES. IN ADDITION, DRUGS/MEDICATIONS CAN CHANGE THE DENSITY OF A BLOOD SPECIMEN, FURTHER CONTRIBUTING TO THIS REPORTED CONDITION. A REVIEW OF SPECIMEN HANDLING PARAMETERS SHOULD BE REVIEWED FOR THIS TUBE TYPE. H3 OTHER TEXT : SEE SECTION H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES PRODUCED INCREASED "DRUG MT-3724" RESULTS AFTER USE IN ONE GROUP OF PATIENTS, MAKING THEIR RESULTS "5 FOLD HIGHER" THAN THE OTHER GROUP WHEN BOTH "SHOULD HAVE BEEN AT THE SAME LEVEL". LOT #'S 7129908, 7184549, 7230760, 7299676, 8044749, 8071527, 8222847, AND 8236730 WERE REPORTED TO HAVE BEEN INVOLVED IN THIS EVENT, BUT IT IS UNKNOWN HOW MANY OCCURRENCES HAPPENED WITHIN EACH LOT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER STATES DRUG MT-3724 INCREASED. TWO GROUPS, ONE GROUP IS 5 FOLD HIGHER THAN THE OTHER GROUP THOUGH BOTH GROUPS SHOULD BE AT THE SAME LEVEL. NO SPECIFIC DATE BUT BIGGEST CHANGE IN LEVELS WAS IN 2018. NO NUMBER OF OCCURRENCES, NO SPECIFIC DATE, NO MEDICAL INTERVENTION, NO TREATMENT CHANGE. LOT 8222847 AND 8236730 WERE USED IN 2019." "DRUG MT-3724 WAS INCREASED IN ONE GROUP WHEN BOTH GROUPS SHOULD HAVE BEEN AT THE SAME LEVEL."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 7129908. MEDICAL DEVICE EXPIRATION DATE: 2018-04-30. DEVICE MANUFACTURE DATE: 2017-05-09. MEDICAL DEVICE LOT #: 7184549. MEDICAL DEVICE EXPIRATION DATE: 2018-06-30. DEVICE MANUFACTURE DATE: 2017-07-03. MEDICAL DEVICE LOT #: 7230760. MEDICAL DEVICE EXPIRATION DATE: 2018-08-31. DEVICE MANUFACTURE DATE: 2017-08-18. MEDICAL DEVICE LOT #: 7299676. MEDICAL DEVICE EXPIRATION DATE: 2018-10-31. DEVICE MANUFACTURE DATE: 2017-10-26. MEDICAL DEVICE LOT #: 8044749. MEDICAL DEVICE EXPIRATION DATE: 2019-01-31. DEVICE MANUFACTURE DATE: 2018-02-13. MEDICAL DEVICE LOT #: 8071527. MEDICAL DEVICE EXPIRATION DATE: 2019-02-28. DEVICE MANUFACTURE DATE: 2018-03-12. MEDICAL DEVICE LOT #: 8222847. MEDICAL DEVICE EXPIRATION DATE: 2019-07-31. DEVICE MANUFACTURE DATE: 2018-08-10. MEDICAL DEVICE LOT #: 8236730. MEDICAL DEVICE EXPIRATION DATE: 2019-08-31. DEVICE MANUFACTURE DATE: 2018-08-24. 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® SST¿ BLOOD COLLECTION TUBES PRODUCED INCREASED "DRUG MT-3724" RESULTS AFTER USE IN ONE GROUP OF PATIENTS, MAKING THEIR RESULTS "5 FOLD HIGHER" THAN THE OTHER GROUP WHEN BOTH "SHOULD HAVE BEEN AT THE SAME LEVEL". LOT #'S 7129908, 7184549, 7230760, 7299676, 8044749, 8071527, 8222847, AND 8236730 WERE REPORTED TO HAVE BEEN INVOLVED IN THIS EVENT, BUT IT IS UNKNOWN HOW MANY OCCURRENCES HAPPENED WITHIN EACH LOT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER STATES DRUG MT-3724 INCREASED. TWO GROUPS, ONE GROUP IS 5 FOLD HIGHER THAN THE OTHER GROUP THOUGH BOTH GROUPS SHOULD BE AT THE SAME LEVEL. NO SPECIFIC DATE BUT BIGGEST CHANGE IN LEVELS WAS IN 2018. NO NUMBER OF OCCURRENCES, NO SPECIFIC DATE, NO MEDICAL INTERVENTION, NO TREATMENT CHANGE. LOT 8222847 AND 8236730 WERE USED IN 2019." "DRUG MT-3724 WAS INCREASED IN ONE GROUP WHEN BOTH GROUPS SHOULD HAVE BEEN AT THE SAME LEVEL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1153951 BD VACUTAINER® SST¿ BLOOD COLLECTION TUBE BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) 367986 SEE SECTION H.10. 50382903679862

    Patients

    Seq Age Sex Outcome Treatment
    1 Other