BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 8750190 · Received July 1, 2019

    Report

    Report Number
    1917413-2019-01685
    Event Type
    Malfunction
    Date Received
    July 1, 2019
    Date of Event
    June 3, 2019
    Report Date
    July 10, 2019
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    UDI-DI
    50382903697149
    PMA / PMN Number
    K945952
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: RETENTION SAMPLES WERE SELECTED FROM BD INVENTORY FOR EVALUATION AND TESTING AND UPON COMPLETION, NO ISSUES WERE OBSERVED RELATING TO STOPPER PULL OUT AS ALL SAMPLES MET SPECIFICATIONS. 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. INVESTIGATION CONCLUSION: BASED ON EVALUATION OF THE RETAIN SAMPLES, THE CUSTOMER¿S INDICATED FAILURE MODE FOR STOPPER PULL OUT WITH THE INCIDENT LOT WAS NOT OBSERVED AS ALL SAMPLES MET THE REQUIRED SPECIFICATIONS. ROOT CAUSE DESCRIPTION: BASED ON THE INVESTIGATION, A ROOT CAUSE COULD NOT BE DETERMINED. THE RETAIN PRODUCT WAS FOUND TO BE IN CONFORMANCE AND MEET RELEASE SPECIFICATIONS. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. THE BD BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. H3 OTHER TEXT : SEE SECTION H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 21 BD VACUTAINER® BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBES FROM LOT # 9095821 WERE TESTED FOR STOPPER PULLOUT FORCE BY RESEARCH AND DEVELOPMENT, AND THE MEAN FORCE WAS FOUND TO BE BELOW THE SPECIFICATION DURING USE. 2 TUBES FROM LOT # 9095822 WERE ALSO TESTED, RESULTING IN THE MINIMUM AND MEAN FORCE FALLING BELOW SPECIFICATION. THIS COMPLAINT WAS CREATED TO CAPTURE THE 5TH OF 5 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING R&D TESTING, WE HAVE IDENTIFIED INSTANCES WHERE THE 2ND STOPPER PULLOUT FORCE FOR SOME TUBES DID NOT MEET OUR SPECIFICATION. (THE 2ND PULLOUT FORCE IS THE FORCE TO REMOVE THE STOPPER AFTER IT HAS BEEN REMOVED AND REINSERTED INTO THE FILLED TUBE.) THE SPECIFIC PRODUCT SKU AND BATCH NUMBERS WHERE THIS OCCURRED ARE LISTED BELOW. (B)(6) 2019, 369714, 9095821, MEAN FORCE BELOW SPECIFICATION; (B)(6) 2019, 369714, 9095822, MINIMUM AND MEAN FORCE BELOW SPECIFICATION.

    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 #: 9095821, MEDICAL DEVICE EXPIRATION DATE: 2020-10-31, DEVICE MANUFACTURE DATE: 2019-04-05. MEDICAL DEVICE LOT #: 9095822, MEDICAL DEVICE EXPIRATION DATE: 2020-10-31, DEVICE MANUFACTURE DATE: 2019-04-05. DEVICE EVALUATED BY MFR: 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 21 BD VACUTAINER® BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBES FROM LOT # 9095821 WERE TESTED FOR STOPPER PULLOUT FORCE BY RESEARCH AND DEVELOPMENT, AND THE MEAN FORCE WAS FOUND TO BE BELOW THE SPECIFICATION DURING USE. 2 TUBES FROM LOT # 9095822 WERE ALSO TESTED, RESULTING IN THE MINIMUM AND MEAN FORCE FALLING BELOW SPECIFICATION. THIS COMPLAINT WAS CREATED TO CAPTURE THE 5TH OF 5 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING R&D TESTING, WE HAVE IDENTIFIED INSTANCES WHERE THE 2ND STOPPER PULLOUT FORCE FOR SOME TUBES DID NOT MEET OUR SPECIFICATION. (THE 2ND PULLOUT FORCE IS THE FORCE TO REMOVE THE STOPPER AFTER IT HAS BEEN REMOVED AND REINSERTED INTO THE FILLED TUBE.) THE SPECIFIC PRODUCT SKU AND BATCH NUMBERS WHERE THIS OCCURRED ARE LISTED BELOW: ON (B)(6) 2019, 13 JUN 2019, 369714, 9095821, MEAN FORCE BELOW SPECIFICATION. ON (B)(6) 2019, 13 JUN 2019, 369714, 9095822, MINIMUM AND MEAN FORCE BELOW SPECIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    545014 BD VACUTAINER® BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) SEE SECTION H.10. 50382903697149

    Patients

    Seq Age Sex Outcome Treatment
    1 Other