BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® 9NC BUFFERED TRISODIUM CITRATE PLUS BLOOD COLLECTION TUBE

    MDR report key: 13840353 · Received March 21, 2022

    Report

    Report Number
    9617032-2022-00232
    Event Type
    Malfunction
    Date Received
    March 21, 2022
    Date of Event
    February 25, 2022
    Report Date
    May 23, 2022
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    UDI-DI
    50382903630474
    PMA / PMN Number
    K013971
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    CORRECTION: AFTER FURTHER REVIEW, THIS WAS NOT FOUND TO BE AN ISSUE WITH CLOTTING. THE FOLLOWING FIELDS HAVE BEEN UPDATED: B.5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT THE BD VACUTAINER® 9NC BUFFERED TRISODIUM CITRATE PLUS BLOOD COLLECTION TUBE HAD ERRONEOUS RESULTS DUE TO PROLONGED PTT ACTIVATION DURING A COAGULATION STUDY. H.6. IMDRF ANNEX A GRID: A0908.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: BD HAD NOT RECEIVED SAMPLES, BUT 2 PHOTOS WERE PROVIDED FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE INDICATED FAILURE MODE FOR ERRONEOUS RESULTS WAS NOT OBSERVED. ADDITIONALLY, RETENTION SAMPLES OF THE INCIDENT LOT WERE SELECTED FROM BD INVENTORY FOR EVALUATION AND UPON COMPLETION, NO ISSUES RELATING TO ERRONEOUS RESULTS WERE OBSERVED. NO DIFFICULTIES WERE ENCOUNTERED DURING BLOOD COLLECTION AND ALL TUBES APPEARED TO EXHIBIT PROPER FILL. BD WAS UNABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE (ERRONEOUS RESULTS) BECAUSE THE DEFECT WAS NOT EVIDENT IN THE TESTING OF THE COMPLAINT LOT SAMPLES. REPLICATES OF BOTH RETAIN AND CONTROL SAMPLES WERE ACCEPTABLE IN TERMS OF BOTH PRECISION AND ACCURACY. LABORATORY ANALYSIS OF RETAIN AND CONTROL SAMPLES DEMONSTRATED CLINICALLY ACCEPTABLE PERFORMANCE FOR ALL VISUAL OBSERVATIONS EVALUATED. THE CITRATE TUBES PERFORMED AS EXPECTED. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOT, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THERE WERE NO RELATED QUALITY ISSUES DURING MANUFACTURING OF THE PRODUCT. THIS COMPLAINT IS UNABLE TO BE CONFIRMED FOR THE INDICATED FAILURE MODE ERRONEOUS RESULTS. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD VACUTAINER® 9NC BUFFERED TRISODIUM CITRATE PLUS BLOOD COLLECTION TUBE HAD PROLONGED PTT ACTIVATION AND CLOTTED DURING A COAGULATION STUDY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "ON A NIGHT SHIFT EARLIER THIS WEEK, COAGULATION STUDIES WERE COLLECTED IN BD VACUTAINER 9NC 0.109M BUFF, NA3, CITRATE, REF (B)(4) LOT 1242115, 1.8 ML MICROTAINER. RESULT THAT WAS RECIEVED BY THE UNIT WAS EXTREMELY PROLONGED. CLINICIAN NOTED THE EXPIRY DATE ON THE TUBES WAS 2022-02 (BELIEVE THIS MEANS IT SHOULDN¿T BE EXPIRED UNTIL THE END OF THE MONTH FEB 28). CLINICIAL REMOVED TUBES FROM THE LAB CART AND I UNDERSTAND THEY WERE DISCARDED. TODAY ANOTHER NURSE CLINICIAN/CHARGE NURSE REPORTED A SIMILAR EVENT ON A DIFFERENT PATIENT. I GUESS SOME OF THE TUBES WERE STILL ON EITHER THE LAB CART OR THE MEGA CART, I REALLY DON'T KNOW WHERE IT CAME FROM. AT ANY RATE, THE PTT WAS AGAIN VERY PROLONGED. THE UNIT CALLED THE LAB FOR TUBES AND WERE SENT BD VACUTAINER BUFF, NA, CITRATE, 0.109M 3.2% REF (B)(4) LOT 1319175 EXP 2022-05-31, 1.8 ML. THE CHARGE NURSE ACKNOWLEDGED THAT SOME CLINICAL CORRECTIONS HAD TAKEN PLACE (FFP AND VIT K I BELIEVE), AND THE COAG STUDIES IN THE SECOND TUBE WERE MORE IN LINE WITH EXPECTED RESULTS."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD VACUTAINER® 9NC BUFFERED TRISODIUM CITRATE PLUS BLOOD COLLECTION TUBE HAD ERRONEOUS RESULTS DUE TO PROLONGED PTT ACTIVATION DURING A COAGULATION STUDY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "ON A NIGHT SHIFT EARLIER THIS WEEK, COAGULATION STUDIES WERE COLLECTED IN BD VACUTAINER 9NC 0.109M BUFF, NA3, CITRATE, REF 363047 LOT 1242115, 1.8 ML MICROTAINER. RESULT THAT WAS RECIEVED BY THE UNIT WAS EXTREMELY PROLONGED. CLINICIAN NOTED THE EXPIRY DATE ON THE TUBES WAS 2022-02 (BELIEVE THIS MEANS IT SHOULDN¿T BE EXPIRED UNTIL THE END OF THE MONTH FEB 28). CLINICIAL REMOVED TUBES FROM THE LAB CART AND I UNDERSTAND THEY WERE DISCARDED. TODAY ANOTHER NURSE CLINICIAN/CHARGE NURSE REPORTED A SIMILAR EVENT ON A DIFFERENT PATIENT. I GUESS SOME OF THE TUBES WERE STILL ON EITHER THE LAB CART OR THE MEGA CART, I REALLY DON'T KNOW WHERE IT CAME FROM. AT ANY RATE, THE PTT WAS AGAIN VERY PROLONGED. THE UNIT CALLED THE LAB FOR TUBES AND WERE SENT BD VACUTAINER BUFF, NA, CITRATE, 0.109M 3.2% REF 363080 LOT 1319175 EXP 2022-05-31, 1.8 ML. THE CHARGE NURSE ACKNOWLEDGED THAT SOME CLINICAL CORRECTIONS HAD TAKEN PLACE (FFP AND VIT K I BELIEVE), AND THE COAG STUDIES IN THE SECOND TUBE WERE MORE IN LINE WITH EXPECTED RESULTS."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD VACUTAINER® 9NC BUFFERED TRISODIUM CITRATE PLUS BLOOD COLLECTION TUBE HAD ERRONEOUS RESULTS DUE TO PROLONGED PTT ACTIVATION DURING A COAGULATION STUDY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "ON A NIGHT SHIFT EARLIER THIS WEEK, COAGULATION STUDIES WERE COLLECTED IN BD VACUTAINER 9NC 0.109M BUFF, NA3, CITRATE, REF (B)(4) LOT 1242115, 1.8 ML MICROTAINER. RESULT THAT WAS RECIEVED BY THE UNIT WAS EXTREMELY PROLONGED. CLINICIAN NOTED THE EXPIRY DATE ON THE TUBES WAS 2022-02 (BELIEVE THIS MEANS IT SHOULDN¿T BE EXPIRED UNTIL THE END OF THE MONTH FEB 28). CLINICIAL REMOVED TUBES FROM THE LAB CART AND I UNDERSTAND THEY WERE DISCARDED. TODAY ANOTHER NURSE CLINICIAN/CHARGE NURSE REPORTED A SIMILAR EVENT ON A DIFFERENT PATIENT. I GUESS SOME OF THE TUBES WERE STILL ON EITHER THE LAB CART OR THE MEGA CART, I REALLY DON'T KNOW WHERE IT CAME FROM. AT ANY RATE, THE PTT WAS AGAIN VERY PROLONGED. THE UNIT CALLED THE LAB FOR TUBES AND WERE SENT BD VACUTAINER BUFF, NA, CITRATE, 0.109M 3.2% REF (B)(4) LOT 1319175 EXP 2022-05-31, 1.8 ML. THE CHARGE NURSE ACKNOWLEDGED THAT SOME CLINICAL CORRECTIONS HAD TAKEN PLACE (FFP AND VIT K I BELIEVE), AND THE COAG STUDIES IN THE SECOND TUBE WERE MORE IN LINE WITH EXPECTED RESULTS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24550 BD VACUTAINER® 9NC BUFFERED TRISODIUM CITRATE PLUS BLOOD COLLECTION TUBE BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 363047 1242115 50382903630474

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown