BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® BUFFERED SODIUM CITRATE BLOOD COLLECTION TUBES

    MDR report key: 7646129 · Received June 28, 2018

    Report

    Report Number
    1917413-2018-03068
    Event Type
    Malfunction
    Date Received
    June 28, 2018
    Date of Event
    June 8, 2018
    Report Date
    August 7, 2018
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    JKA
    UDI-DI
    50382903630832
    PMA / PMN Number
    K013971
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BD RECEIVED SAMPLES FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE SAMPLES WERE EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE FOR OVERFILL WITH THE INCIDENT LOT WAS NOT OBSERVED. EVALUATION/TESTING OF THE CUSTOMER SAMPLES WAS PERFORMED AND OVERFILL WAS NOT 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 A CAPA 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 · 0

    IT WAS REPORTED THAT THE BD VACUTAINER® BUFFERED SODIUM CITRATE BLOOD COLLECTION TUBES WERE ¿OVERFILLING WELL ABOVE THE MARKING LINE¿. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 8061553; MEDICAL DEVICE EXPIRATION DATE: 12/31/2018 ; DEVICE MANUFACTURE DATE: 03/02/2018; MEDICAL DEVICE LOT #: 7305990; MEDICAL DEVICE EXPIRATION DATE: 2018-08-31; DEVICE MANUFACTURE DATE: 2017-11-01. 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® BUFFERED SODIUM CITRATE BLOOD COLLECTION TUBES WERE ¿OVERFILLING WELL ABOVE THE MARKING LINE¿. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    487440 BD VACUTAINER® BUFFERED SODIUM CITRATE BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. SEE H.10. 50382903630832

    Patients

    Seq Age Sex Outcome Treatment
    1 Other