BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® LITHIUM HEPARINN (LH) 158 USP UNITS BLOOD COLLECTION TUBES

    MDR report key: 8727875 · Received June 24, 2019

    Report

    Report Number
    1917413-2019-01631
    Event Type
    Malfunction
    Date Received
    June 24, 2019
    Date of Event
    June 6, 2019
    Report Date
    July 30, 2019
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    UDI-DI
    50382903678780
    PMA / PMN Number
    K945952
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR EVALUATION; THEREFORE, THE INVESTIGATION WAS LIMITED. 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. THE CUSTOMER¿S PRACTICE AS DESCRIBED IS NOT COVERED BY OUR IFU HENCE IS CONSIDERED OFF LABEL USE. INVESTIGATION CONCLUSION: AS NO SAMPLES OR PHOTOS WERE RECEIVED FOR EVALUATION, THE CUSTOMER'S INDICATED FAILURE MODE WAS NOT OBSERVED BY BD. ROOT CAUSE DESCRIPTION: AS THERE WAS NO SAMPLE OR PHOTO AVAILABLE FOR EVALUATION, A ROOT CAUSE COULD NOT BE DETERMINED. ADDITIONALLY THE CUSTOMER¿S PRACTICE AS DESCRIBED IS NOT COVERED BY OUR IFU HENCE IS CONSIDERED OFF LABEL USE. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD VACUTAINER® LITHIUM HEPARINN (LH) 158 USP UNITS BLOOD COLLECTION TUBES HAD ISSUES WITH THE CELL HARVEST YIELD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 367878 BATCH NO: 8061712 IT WAS REPORTED THE CUSTOMER EXPERIENCED SOME ISSUES WITH THE CELL HARVEST YIELD. DESCRIPTION OF EVENT: OUR LABORATORY HAS BEEN EXPERIENCING SOME ISSUES WITH THE CELL HARVEST YIELD THEY WERE GETTING FROM BONE MARROW AND PERIPHERAL BLOOD SAMPLES FOR CHROMOSOME ANALYSIS. THEY RECENTLY DID A LARGE BATCH OF TESTING AND NOTED THAT ALL THE AFFECTED SAMPLES HAD A CORRESPONDING LOT # CLOSE TO EXPIRY.

    Additional Manufacturer Narrative · 1

    (B)(6). DEVICE EVALUATED BY MFR: A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD VACUTAINER® LITHIUM HEPARIN (LH) 158 USP UNITS BLOOD COLLECTION TUBES HAD ISSUES WITH THE CELL HARVEST YIELD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 367878, BATCH NO: 8061712. IT WAS REPORTED THE CUSTOMER EXPERIENCED SOME ISSUES WITH THE CELL HARVEST YIELD. DESCRIPTION OF EVENT: OUR LABORATORY HAS BEEN EXPERIENCING SOME ISSUES WITH THE CELL HARVEST YIELD THEY WERE GETTING FROM BONE MARROW AND PERIPHERAL BLOOD SAMPLES FOR CHROMOSOME ANALYSIS. THEY RECENTLY DID A LARGE BATCH OF TESTING AND NOTED THAT ALL THE AFFECTED SAMPLES HAD A CORRESPONDING LOT # CLOSE TO EXPIRY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522151 BD VACUTAINER® LITHIUM HEPARINN (LH) 158 USP UNITS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) 8061712 50382903678780

    Patients

    Seq Age Sex Outcome Treatment
    1 Other