BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® LITHIUM HEPARINN (LH) BLOOD COLLECTION TUBES

    MDR report key: 18043064 · Received October 31, 2023

    Report

    Report Number
    1917413-2023-01112
    Event Type
    Malfunction
    Date Received
    October 31, 2023
    Date of Event
    October 11, 2023
    Report Date
    November 28, 2023
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    UDI-DI
    00382903678785
    PMA / PMN Number
    K945952
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED AND/OR ADDITIONAL INFORMATION. B.5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED WHEN USING THE BD VACUTAINER® LITHIUM HEPARIN (LH) BLOOD COLLECTION TUBES HAS ISSUES WITH HEMOLYSIS. THIS EVENT OCCURRED 10 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: IT WAS REPORTED BY THE CUSTOMER THAT LOT#: 3111828 WITH COAGULATION. THEY REPORT THAT " BLOOD THAT IS DRAWN GOES GLOSSY AND CANNOT BE USED". H.6. IMDRF ANNEX A: A0302 - DEVICE INGREDIENT OR REAGENT PROBLEM (2910).

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES, BUT 2 PHOTOS WERE PROVIDED FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE INDICATED FAILURE MODE FOR HEMOLYSIS WAS OBSERVED. ADDITIONALLY, 100 RETENTION SAMPLES FROM BD INVENTORY WERE VISUALLY INSPECTED WITH NO ISSUES IDENTIFIED. COMPLAINTS FOR SAMPLE QUALITY ARE UNDER STATISTICAL CONTROL FOR THE MONTH OF (B)(6) 2023. AT THIS TIME, FURTHER TESTING IS NOT INDICATED. 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 HAS BEEN CONFIRMED FOR HEMOLYSIS. 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. BD QUALITY WILL CONTINUE TO MONITOR SAMPLE QUALITY COMPLAINTS.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® LITHIUM HEPARIN (LH) BLOOD COLLECTION TUBES HAS ISSUES WITH HEMOLYSIS. THIS EVENT OCCURRED 10 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: IT WAS REPORTED BY THE CUSTOMER THAT LOT#: 3111828 WITH COAGULATION. THEY REPORT THAT " BLOOD THAT IS DRAWN GOES GLOSSY AND CANNOT BE USED".

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® LITHIUM HEPARINN (LH) BLOOD COLLECTION TUBES HAS ISSUES WITH CLOTTING. THIS EVENT OCCURRED 10 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: IT WAS REPORTED BY THE CUSTOMER THAT LOT#: 3111828 WITH COAGULATION. THEY REPORT THAT " BLOOD THAT IS DRAWN GOES GLOSSY AND CANNOT BE USED".

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® LITHIUM HEPARINN (LH) BLOOD COLLECTION TUBES HAS ISSUES WITH HEMOLYSIS. THIS EVENT OCCURRED 10 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: IT WAS REPORTED BY THE CUSTOMER THAT LOT#: 3111828 WITH COAGULATION. THEY REPORT THAT " BLOOD THAT IS DRAWN GOES GLOSSY AND CANNOT BE USED".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2112110 BD VACUTAINER® LITHIUM HEPARINN (LH) BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) 3111828 00382903678785

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown