BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 7861526 · Received September 10, 2018

    Report

    Report Number
    9617032-2018-02744
    Event Type
    Malfunction
    Date Received
    September 10, 2018
    Date of Event
    August 21, 2018
    Report Date
    October 5, 2018
    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
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    BD RECEIVED SAMPLES FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE CUSTOMER SAMPLES WERE EVALUATED ALONG WITH RETENTION SAMPLES OF THE INCIDENT LOT SELECTED FROM BD INVENTORY. THE CUSTOMER AND RETENTION SAMPLES WERE TESTED AND THE CUSTOMER'S INDICATED FAILURE MODE FOR UNDERFILL 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. THE INVESTIGATION IS STILL ON-GOING AND IMPROVEMENTS WILL BE MADE AS THE POTENTIAL CAUSES OF THIS ISSUE ARE IDENTIFIED. BASED ON EVALUATION OF THE CUSTOMER SAMPLES, THE CUSTOMER¿S INDICATED FAILURE MODE FOR UNDERFILL WITH THE INCIDENT LOT WAS NOT OBSERVED. EVALUATION/TESTING OF THE RETAIN SAMPLES WAS ALSO CONDUCTED AND UNDEFILL 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. (B)(4). RATIONALE: BASED ON AN ASSESSMENT OF SEVERITY AND FREQUENCY, IT WAS DETERMINED THAT A CAPA IS REQUIRED AT THIS TIME IN ORDER TO DETERMINE THE ROOT CAUSE ASSOCIATED WITH THIS ISSUE AND IMPLEMENT CORRECTIVE ACTIONS. THE INVESTIGATION IS CURRENTLY ON-GOING AND FURTHER IMPROVEMENTS WILL BE MADE AS THE POTENTIAL ROOT CAUSE(S) ARE IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD VACUTAINER 9NC 0.109M BUFFERED TRISODIUM CITRATE PLUS BLOOD COLLECTION TUBES ARE UNDERFILLING. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY, OR MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 8060627, MEDICAL DEVICE EXPIRATION DATE: 2018-11-30, DEVICE MANUFACTURE DATE: 2018-03-01. MEDICAL DEVICE LOT #: 8024702, MEDICAL DEVICE EXPIRATION DATE: 2018-10-31, DEVICE MANUFACTURE DATE: 2018-01-24. MEDICAL DEVICE LOT #: 8115569, MEDICAL DEVICE EXPIRATION DATE: 2019-01-31, DEVICE MANUFACTURE DATE: 2018-04-25. (B)(6). 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 BD VACUTAINER® 9NC 0.109M BUFFERED TRISODIUM CITRATE PLUS BLOOD COLLECTION TUBES ARE UNDERFILLING. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY, OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703915 BD VACUTAINER® 9NC 0.109M BUFFERED TRISODIUM CITRATE PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) SEE H.10. 50382903630481

    Patients

    Seq Age Sex Outcome Treatment
    1 Other