BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® 9NC 0.109M BUFFERED TRISODIUM CITRATE PLUS BLOOD COLLECTION TUBE

    MDR report key: 9192670 · Received October 15, 2019

    Report

    Report Number
    9617032-2019-01176
    Event Type
    Malfunction
    Date Received
    October 15, 2019
    Date of Event
    September 25, 2019
    Report Date
    December 12, 2019
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    UDI-DI
    50382903630481
    PMA / PMN Number
    K013971
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: BD RECEIVED SAMPLES FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE SAMPLES WERE EVALUATED AND DRAW ISSUES WITH THE INCIDENT LOT WAS OBSERVED. EVALUATION/TESTING OF THE CUSTOMER SAMPLES WAS PERFORMED AND UNDERFILL WAS OBSERVED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR THE INCIDENT LOT 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. BD HAS INITIATED FURTHER INVESTIGATION RELATING TO THIS ISSUE THROUGH CAPA (B)(4) AND POTENTIAL CAUSES HAVE BEEN IDENTIFIED. AS A RESULT, CORRECTIVE ACTIONS HAVE BEEN ESTABLISHED AND ARE IN THE PROCESS OF BEING IMPLEMENTED.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT THE BD VACUTAINER® 9NC 0.109M BUFFERED TRISODIUM CITRATE PLUS BLOOD COLLECTION TUBE HAS BEEN FOUND EXPERIENCING ERRONEOUS RESULTS DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: FOLLOWING YOUR RETURN ON LOT 9031922 AND THE ABSENCE OF ANOMALIES NOTED BY OUR SUPPLIER ON OUR PLCS, WE DECIDED TO PUT BACK INTO CIRCULATION THE LOT OF CITRATED TUBES 9031922. AS SOON AS IT WAS REUSED AGAIN, WE HAD THE ALARMS ON OUR Q.I.P. CONTROLLERS FOR INSUFFICIENT QUANTITY ((B)(6) 2019). I WENT THROUGH OUR RESULTS AGAIN TO ELIMINATE OUTLIERS LIKE THE FIRST TIME. I DIDN'T FIND ANY. WE THEREFORE DECIDED TO WORK AGAIN WITH AN OPEN CAP (NO ALARMS OR OUTLIERS AND NO POSSIBILITY TO REMOVE ALL THE LABELS FROM THE TUBES TO CHECK THE BATCH NUMBER UPON RECEIPT AT THE LABORATORY).

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT THE BD VACUTAINER® 9NC 0.109M BUFFERED TRISODIUM CITRATE PLUS BLOOD COLLECTION TUBE HAS BEEN FOUND EXPERIENCING ERRONEOUS RESULTS DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: FOLLOWING YOUR RETURN ON LOT 9031922 AND THE ABSENCE OF ANOMALIES NOTED BY OUR SUPPLIER ON OUR PLCS, WE DECIDED TO PUT BACK INTO CIRCULATION THE LOT OF CITRATED TUBES 9031922. AS SOON AS IT WAS REUSED AGAIN, WE HAD THE ALARMS ON OUR Q.I.P. CONTROLLERS FOR INSUFFICIENT QUANTITY ((B)(6) 2019). I WENT THROUGH OUR RESULTS AGAIN TO ELIMINATE OUTLIERS LIKE THE FIRST TIME. I DIDN'T FIND ANY. WE THEREFORE DECIDED TO WORK AGAIN WITH AN OPEN CAP (NO ALARMS OR OUTLIERS AND NO POSSIBILITY TO REMOVE ALL THE LABELS FROM THE TUBES TO CHECK THE BATCH NUMBER UPON RECEIPT AT THE LABORATORY).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    984130 BD VACUTAINER® 9NC 0.109M BUFFERED TRISODIUM CITRATE PLUS BLOOD COLLECTION TUBE BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 9031922 50382903630481

    Patients

    Seq Age Sex Outcome Treatment
    1 Other