BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBE

    MDR report key: 12169785 · Received July 14, 2021

    Report

    Report Number
    1917413-2021-00622
    Event Type
    Malfunction
    Date Received
    July 14, 2021
    Date of Event
    June 24, 2021
    Report Date
    August 4, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    UDI-DI
    50382903630832
    PMA / PMN Number
    K013971
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR INVESTIGATION. THEREFORE, 10 RETENTION SAMPLES OF LOTS 1074688, 1040874, AND 1040875, WERE EVALUATED BY FUNCTIONAL TESTING AND NO ISSUES WERE OBSERVED RELATING TO OVERFILL AS ALL SAMPLES MET SPECIFICATIONS. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOT, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THERE WERE NO RELATED QUALITY ISSUES DURING MANUFACTURING OF THE PRODUCT. THIS COMPLAINT IS UNABLE TO BE CONFIRMED FOR THE INDICATED FAILURE MODE OVERFILL. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. H3 OTHER TEXT : SEE H10

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBE, THE DEVICE EXPERIENCED OVERFILL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: IT WAS REPORTED THAT THE TUBES HAVE BEEN OVERFILLING. NOT SURE WHO I AM TO CONTACT HERE BUT THE LAST ORDER OF BLUE TOPS HAVE BEEN FILLING ALL THE WAY UP TO THE CAP. SO FAR WE HAVE MULTIPLE LOT NUMBERS THAT ARE FILLING UP ALL THE WAY TO THE TOP. IT¿S NOT CONSISTENT THOUGH, IN THAT SOME PLACES HAVE REPORTED NO OVERFILLING OF TUBES WITH THOSE LOTS.

    Additional Manufacturer Narrative · 1

    "MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1040874, MEDICAL DEVICE EXPIRATION DATE: 2021-11-30, DEVICE MANUFACTURE DATE: 2021-02-09. MEDICAL DEVICE LOT #: 1074688, MEDICAL DEVICE EXPIRATION DATE: 2021-12-31, DEVICE MANUFACTURE DATE: 2021-03-15. MEDICAL DEVICE LOT #: 1040875, MEDICAL DEVICE EXPIRATION DATE: 2021-11-30, DEVICE MANUFACTURE DATE: 2021-02-09. 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 WHEN USING THE BD VACUTAINER® BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBE, THE DEVICE EXPERIENCED OVERFILL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: IT WAS REPORTED THAT THE TUBES HAVE BEEN OVERFILLING. NOT SURE WHO I AM TO CONTACT HERE BUT THE LAST ORDER OF BLUE TOPS HAVE BEEN FILLING ALL THE WAY UP TO THE CAP. SO FAR WE HAVE MULTIPLE LOT NUMBERS THAT ARE FILLING UP ALL THE WAY TO THE TOP. IT¿S NOT CONSISTENT THOUGH, IN THAT SOME PLACES HAVE REPORTED NO OVERFILLING OF TUBES WITH THOSE LOTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1061744 BD VACUTAINER BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBE BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) 363083 SEE H.10. 50382903630832

    Patients

    Seq Age Sex Outcome Treatment
    1