BEUDAMED
    FDA Adverse Event Injury Summary report: N

    13 X 75 MM X 4.0 ML BD VACUTAINER® PLUS PLASTIC WHOLE BLOOD TUBE

    MDR report key: 5386487 · Received January 22, 2016

    Report

    Report Number
    1917413-2016-00002
    Event Type
    Injury
    Date Received
    January 22, 2016
    Date of Event
    January 15, 2016
    Report Date
    February 24, 2016
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    JKA
    PMA / PMN Number
    K981013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: PER THE INVESTIGATION COMPLETED ON 2/8/2016, THE REPORTED PRODUCT MALFUNCTION IS NOT CONFIRMED. THEREFORE, THE ADVERSE EVENT AND/OR PRODUCT PROBLEM FIELD WILL BE CHANGED TO ADVERSE EVENT ONLY. ADVERSE EVENT AND/OR PRODUCT PROBLEM: ADVERSE EVENT.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A SAMPLE IS AVAILABLE FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN

    Additional Manufacturer Narrative · 1

    A LOT # WAS PROVIDED WHEN THE SAMPLE WAS RETURNED FOR EVALUATION. LOT #: 5210793 MEDICAL DEVICE EXPIRATION DATE: 12/31/2016. DEVICE MANUFACTURE DATE: 7/29/2015. DEVICE EVALUATION: RESULTS: BLOOD SAMPLES WERE COLLECTED FROM ONE EMPLOYEE DONOR INTO A TOTAL OF NINE TUBES FROM THE INCIDENT LOT AND ONE TUBE FROM CONTROL LOT (REORDER # (B)(4), LOT # 5120667, EXP. 09/2016). STANDARD VENIPUNCTURE TECHNIQUES WITH A BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET (REORDER # (B)(4), LOT # 5229548, EXP. 08/2017) WERE EMPLOYED. IMMEDIATELY AFTER FILLING, THE SAMPLES WERE MIXED BY 10 COMPLETE INVERSIONS, PLACED UPRIGHT IN A RACK AT ROOM TEMPERATURE. NEXT, THE CONTROL AND INCIDENT LOT TUBES WERE PLACED ON A MECHANICAL ROTATOR FOR 5 (±2) MINUTES. ALL SAMPLES WERE ASSAYED ON THE BECKMAN COULTER LH 750 AND CBC DATA WAS COLLECTED. IMMEDIATELY AFTER FILLING, THE SAMPLES WERE MIXED BY 10 COMPLETE INVERSIONS, PLACED UPRIGHT IN A RACK AT ROOM TEMPERATURE. NEXT, THE CONTROL AND INCIDENT LOT TUBES WERE PLACED ON A MECHANICAL ROTATOR FOR 5 (±2) MINUTES. ALL SAMPLES WERE ASSAYED ON THE COULTER LH 750 AND CBC DATA WAS COLLECTED. NINE CUSTOMER RETURNED SAMPLES WERE VISUALLY INSPECTED FOR THE PRESENCE OF K2EDTA ADDITIVE PRIOR TO ANALYSIS. ALL NINE CUSTOMER SAMPLES INSPECTED CONTAINED K2EDTA SPRAY COATING ON THE INNER WALLS OF THE INCIDENT LOT TUBES. THERE WERE NO DIFFICULTIES ENCOUNTERED DURING SAMPLE COLLECTION OR SAMPLE ANALYSIS. THE INCIDENT AND CONTROL LOT TUBES ANALYZED DISPLAYED NO WBC, RBC OR PLATELET FLAGS. ALL BLOOD CELL HISTOGRAMS WERE NORMALLY DISTRIBUTED ON THE COULTER LH 750 SCATTER PLOTS. ALL NINE INCIDENT LOT TUBES PERFORMED AS EXPECTED AND NO ISSUES WERE OBSERVED DURING THE CLINICAL INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 5210793. CONCLUSION: AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED AS THE EVALUATED SAMPLES AND REVIEW OF THE DEVICE HISTORY RECORD SHOWED NO IRREGULARITIES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A 13 X 75 MM X 4.0 ML BD VACUTAINER® PLUS PLASTIC WHOLE BLOOD TUBE WAS USED TO DRAW LABS FOR A PATIENT IN AN EMERGENCY DEPARTMENT. THE RESULTS OF THE LAB WORK SHOWED A WBC COUNT OF 26,000 AND A HGB OF 6. THE BLOOD WAS DRAWN WITH A SYRINGE FROM AN IV START AND NO FLUIDS HAD BEEN ADMINISTERED. BECAUSE OF THESE LAB RESULTS THE PATIENT RECEIVED TWO UNITS OF BLOOD. THE PATIENT WAS ALSO ADMITTED TO THE HOSPITAL FOR PNEUMONIA. THE PATIENT HAD LABS REDRAWN THE FOLLOWING DAY AND THE RESULTS SHOWED A WBC COUNT OF 13,900 AND AN HGB OF 13.3. HOWEVER, A REDRAW THAT WAS DONE THE DAY BEFORE IN THE EMERGENCY DEPARTMENT WAS ALSO TESTED AND SHOWED A WBC OF 16,000 AND AN HGB OF 12.2. THE EMERGENCY DEPARTMENT REDRAW WAS DONE AND THE TUBES WERE LABELED IN THE PATIENT'S ROOM AND WITNESSED BY THE PATIENT'S FAMILY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    44430 13 X 75 MM X 4.0 ML BD VACUTAINER® PLUS PLASTIC WHOLE BLOOD TUBE WHOLE BLOOD TUBE JKA BECTON, DICKINSON & CO. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention