BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBES

    MDR report key: 7440489 · Received April 18, 2018

    Report

    Report Number
    1917413-2018-00773
    Event Type
    Malfunction
    Date Received
    April 18, 2018
    Date of Event
    November 8, 2016
    Report Date
    May 10, 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
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    "MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 6187963. MEDICAL DEVICE EXPIRATION DATE: 2017-04-30. DEVICE MANUFACTURE DATE: 2016-07-05 . MEDICAL DEVICE LOT #: 6187962. MEDICAL DEVICE EXPIRATION DATE: 2017-04-30. DEVICE MANUFACTURE DATE: 2016-07-05.

    Additional Manufacturer Narrative · 1

    INVESTIGATION CONCLUSION: THERE WERE NO RELATED QUALITY NOTIFICATIONS ON 6187962 OR 6187963. ALL PROCESS AND FINAL INSPECTIONS COMPLY WITH SPECIFICATION REQUIREMENTS. ROOT CAUSE DESCRIPTION: THERE WAS NO SAMPLE AND/OR PHOTO AVAILABLE FOR EVALUATION. BASED ON THE INVESTIGATION, A ROOT CAUSE COULD NOT BE DETERMINED WITHIN THE SCOPE OF THIS EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD VACUTAINER® BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBES ARE OVERFILLING DURING USE. NO INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282652 BD VACUTAINER® BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. 6187963 50382903630832

    Patients

    Seq Age Sex Outcome Treatment
    1 Other