BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® K2E PLUS BLOOD COLLECTION TUBES

    MDR report key: 9167081 · Received October 8, 2019

    Report

    Report Number
    9617032-2019-01137
    Event Type
    Malfunction
    Date Received
    October 8, 2019
    Date of Event
    September 23, 2019
    Report Date
    October 14, 2019
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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; 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. THE CUSTOMER¿S PRACTICE AS DESCRIBED IS NOT COVERED BY OUR IFU HENCE IS CONSIDERED OFF LABEL USE. IT MAY BE OF VALUE TO REVIEW THEIR PROCEDURES AND PROTOCOLS TO ASSURE PROPER PRACTICE. BD RECOMMENDS PAXGENE BLOOD DNA SYSTEMS (IVD) WHOSE PERFORMANCE HAS BEEN VERIFIED TO ENSURE SUFFICIENT DNA QUANTITY AND QUALITY FOR MOLECULAR DIAGNOSTIC ASSAYS THAT REQUIRE DNA FROM WHOLE BLOOD. (REF: (B)(4). HTTP://WWW.BDBIOSCIENCES.COM/US/APPLICATIONS/BLOOD-COLLECTION/CELL-BIOMARKER-PRESERVATION/PAXGENEREG-BLOOD-DNA-TUBE/P/761165) H3 OTHER TEXT : SEE SECTION H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BLOOD COLLECTED IN THE BD VACUTAINER® K2E PLUS BLOOD COLLECTION TUBE PRODUCED DIFFERENT QPCR RESULTS FROM THE BLOOD COLLECTED IN THE 10ML VACUTAINERS DURING USE. THIS OCCURRED ON 5 SEPARATE OCCASIONS, BUT THE DATES AND/OR PATIENT INFORMATION ARE UNKNOWN. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "OBSERVED VERY DIVERGENT QPCR RESULTS FROM MATCHED BLOOD COLLECTED IN 4ML AND 10ML K2EDTA VACUTAINERS (P/N: 367839 AND 367825 RESPECTIVELY)." "IN PAIRED SAMPLE TESTING WE HAVE OBSERVED VERY DIVERGENT QPCR RESULTS FROM MATCHED BLOOD COLLECTED IN 4ML AND 10ML K2EDTA VACUTAINERS (P/N: 367839 AND 367825 RESPECTIVELY). FROM THE CATALOGUE IT SEEMS THE ONLY DISCERNIBLE DIFFERENCE BETWEEN THESE TWO TUBES IS THE VOLUME AND THE LABEL TYPE WHICH SHOULD NOT BE EXPECTED TO IMPACT QPCR."

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BLOOD COLLECTED IN THE BD VACUTAINER® K2E PLUS BLOOD COLLECTION TUBE PRODUCED DIFFERENT QPCR RESULTS FROM THE BLOOD COLLECTED IN THE 10ML VACUTAINERS DURING USE. THIS OCCURRED ON 5 SEPARATE OCCASIONS, BUT THE DATES AND/OR PATIENT INFORMATION ARE UNKNOWN. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "OBSERVED VERY DIVERGENT QPCR RESULTS FROM MATCHED BLOOD COLLECTED IN 4ML AND 10ML K2EDTA VACUTAINERS (P/N 367839 AND 367825 RESPECTIVELY)." "IN PAIRED SAMPLE TESTING WE HAVE OBSERVED VERY DIVERGENT QPCR RESULTS FROM MATCHED BLOOD COLLECTED IN 4ML AND 10ML K2EDTA VACUTAINERS (P/N 367839 AND 367825 RESPECTIVELY). FROM THE CATALOGUE IT SEEMS THE ONLY DISCERNIBLE DIFFERENCE BETWEEN THESE TWO TUBES IS THE VOLUME AND THE LABEL TYPE WHICH SHOULD NOT BE EXPECTED TO IMPACT QPCR."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    959438 BD VACUTAINER® K2E PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other