BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® PLUS PLASTIC WHOLE BLOOD TUBE

    MDR report key: 7328738 · Received March 9, 2018

    Report

    Report Number
    1917413-2018-00059
    Event Type
    Malfunction
    Date Received
    March 9, 2018
    Date of Event
    January 3, 2018
    Report Date
    June 19, 2018
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    GIM
    UDI-DI
    50382903678612
    PMA / PMN Number
    K981013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR EVALUATION; THEREFORE, THE INVESTIGATION WAS LIMITED. RETENTION SAMPLES WERE VISUALLY INSPECTED FOR THE PRESENCE OF EDTA ADDITIVE, AND ALL TUBES WERE FOUND TO CONTAIN EDTA SPRAY COATING ON THE INNER WALLS OF THE TUBE. FOLLOWING VISUAL INSPECTION, ALL SAMPLES WERE TESTED FOR THE AMOUNT OF THE EDTA ADDITIVE AND ALL SAMPLES FROM 7100934 WERE WITHIN SPECIFICATION REQUIREMENTS, HOWEVER ONE SAMPLE FROM 7180974 WAS FOUND TO HAVE LESS ADDITIVE. 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 PLATELET CLUMPING WITH THE INCIDENT LOT WAS OBSERVED FOR LOT 7180974 BUT NOT IN 710093. ROOT CAUSE DESCRIPTION: BASED ON THE INVESTIGATION, THE MOST LIKELY ROOT CAUSE WAS DETERMINED TO BE RELATED TO A MANUFACTURING ISSUE. AS A RESULT, BD HAS REVIEWED SPECIFIC AREAS IN THE MANUFACTURING PROCESS WHERE THE CAUSE OF THIS ISSUE MAY HAVE ORIGINATED THE INVESTIGATION HAS IDENTIFIED THE MOST LIKELY ROOT CAUSES AND CORRECTIVE ACTIONS HAVE BEEN IMPLEMENTED. RATIONALE: 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.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 7180974. MEDICAL DEVICE EXPIRATION DATE: 2018-11-30. DEVICE MANUFACTURE DATE: 2017-06-29. MEDICAL DEVICE LOT #: 7100934. MEDICAL DEVICE EXPIRATION DATE: 2018-08-31. DEVICE MANUFACTURE DATE: 2017-04-10.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE A BD VACUTAINER® PLUS PLASTIC WHOLE BLOOD TUBE MALFUNCTIONED AS THERE WERE ¿¿PLT CLOTTING AND ERRORS WITH THE TRIAGE METER BIOSITE FOR CPMK AND TROPONIN.¿ THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171837 BD VACUTAINER® PLUS PLASTIC WHOLE BLOOD TUBE WHOLE BLOOD TUBE GIM BECTON, DICKINSON & CO. SEE H.10. 50382903678612

    Patients

    Seq Age Sex Outcome Treatment
    1 Other