BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® BUFFERED SODIM CITRATE BLOOD COLLECTION TUBE

    MDR report key: 7411315 · Received April 10, 2018

    Report

    Report Number
    1917413-2018-00695
    Event Type
    Malfunction
    Date Received
    April 10, 2018
    Date of Event
    February 13, 2018
    Report Date
    April 6, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    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 #: 7279721, MEDICAL DEVICE EXPIRATION DATE: 2018-07-31, DEVICE MANUFACTURE DATE: 2017-10-06. MEDICAL DEVICE LOT #: 7305990, MEDICAL DEVICE EXPIRATION DATE: 2018-08-31, DEVICE MANUFACTURE DATE: 2017-11-01. MEDICAL DEVICE LOT #: 7279715, MEDICAL DEVICE EXPIRATION DATE: 2018-07-31, DEVICE MANUFACTURE DATE: 2017-10-06. MEDICAL DEVICE LOT #: 7279718, MEDICAL DEVICE EXPIRATION DATE: 2018-07-31, DEVICE MANUFACTURE DATE: 2017-10-06. MEDICAL DEVICE LOT #: UNKNOWN, MEDICAL DEVICE EXPIRATION DATE: UNKNOWN, DEVICE MANUFACTURE DATE: UNKNOWN. MEDICAL DEVICE LOT #: 7256765, MEDICAL DEVICE EXPIRATION DATE: 2018-06-30, DEVICE MANUFACTURE DATE: 2017-09-13. MEDICAL DEVICE LOT #: 7180816, MEDICAL DEVICE EXPIRATION DATE: 2018-04-30, DEVICE MANUFACTURE DATE: 2017-06-29. MEDICAL DEVICE LOT #: 7180814, MEDICAL DEVICE EXPIRATION DATE: 2018-04-30, DEVICE MANUFACTURE DATE: 2017-06-29. INVESTIGATION: INVESTIGATION SUMMARY: BD RECEIVED SAMPLES FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE SAMPLES WERE EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE FOR OVERFILLING WITH THE INCIDENT LOT WAS NOT OBSERVED. DRAW TESTING OF THE CUSTOMER SAMPLES WAS PERFORMED AND ALL TUBES DREW WITHIN THE REQUIRED SPECIFICATIONS. A REVIEW OF THE DEVICE HISTORY RECORDS WAS COMPLETED FOR THE INCIDENT LOTS 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. THE INVESTIGATION IS STILL ON-GOING AND IMPROVEMENTS WILL BE MADE AS THE POTENTIAL CAUSES OF THIS ISSUE ARE IDENTIFIED. INVESTIGATION CONCLUSION: BASED ON EVALUATION OF THE CUSTOMER SAMPLES, THE CUSTOMER¿S INDICATED FAILURE MODE FOR OVERFILLING WITH THE INCIDENT LOT WAS NOT OBSERVED. FURTHER INVESTIGATION HAS BEEN INITIATED THROUGH A CAPA. THE INVESTIGATION IS STILL ON-GOING AND IMPROVEMENTS WILL BE MADE AS THE POTENTIAL CAUSES ARE IDENTIFIED. ROOT CAUSE DESCRIPTION: A CAPA HAS BEEN INITIATED TO DOCUMENT FURTHER INVESTIGATION AND ROOT CAUSE ANALYSIS RELATING TO THIS ISSUE. THE INVESTIGATION IS CURRENTLY ON-GOING AND WILL BE UPDATED AS THE POTENTIAL ROOT CAUSE(S) ARE IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT EIGHT BD VACUTAINER® BUFFERED SODIM CITRATE BLOOD COLLECTION TUBE WERE OVERFILLED. THE RESULTS CROSSED OVER TO GSS AND WERE RELEASED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254247 BD VACUTAINER® BUFFERED SODIM CITRATE BLOOD COLLECTION TUBE BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. SEE H.10. 50382903630832

    Patients

    Seq Age Sex Outcome Treatment
    1 Other