BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES

    MDR report key: 16109307 · Received January 5, 2023

    Report

    Report Number
    1024879-2022-00767
    Event Type
    Malfunction
    Date Received
    January 5, 2023
    Date of Event
    December 6, 2022
    Report Date
    March 16, 2023
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    00382903679867
    PMA / PMN Number
    BK050036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6. INVESTIGATION SUMMARY: CATALOG NUMBER: 367983. BATCH NUMBER: 2161703. BD HAD NOT RECEIVED SAMPLES, BUT 2 PHOTOS WERE PROVIDED FOR INVESTIGATION. AFTER REVIEW AND ANALYSIS OF THE CUSTOMER RECEIVED PHOTO, WITH THE FIRST PHOTO BD IS ABLE TO CONFIRM MISSING ADDITIVE. IN THE SECOND PHOTO, BD IS ABLE TO CONFIRM THE REPORTED FAILURE MODES OF FIBRIN AND POOR BARRIER SEPARATION WITHIN THE TUBE. ADDITIONALLY, RETENTION SAMPLES OF THE INCIDENT LOT WERE SELECTED FROM BD INVENTORY FOR FURTHER EVALUATION FOR POOR BARRIER SEPARATION AND FIBRIN: BD WAS UNABLE TO DUPLICATE THE CUSTOMER¿S INDICATED FAILURE OF POOR BARRIER SEPARATION BECAUSE THE DEFECT WAS NOT EVIDENT IN THE TESTING OF THE RETENTION LOT SAMPLES. REPLICATES OF BOTH RETAIN AND CONTROL SAMPLES TESTED DEMONSTRATED CLINICALLY ACCEPTABLE PERFORMANCE FOR ALL VISUAL OBSERVATIONS EVALUATED. HOWEVER, BD WAS ABLE TO DUPLICATE THE CUSTOMER¿S INDICATED FAILURE OF FIBRIN STRANDS AS THE DEFECT WAS PRESENT IN TESTING OF THE RETENTION LOT SAMPLES. 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 POOR BARRIER SEPARATION AND MISSING ADDITIVE BASED ON THE PHOTOS PROVIDED. THIS COMPLAINT HAS BEEN CONFIRMED FOR FIBRIN BASED ON THE TESTING OF THE RETENTION SAMPLES. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. PRODUCTION RECORDS INDICATED A CLOGGED NOZZLE; HOWEVER ALL PROCESS AND FINAL INSPECTIONS COMPLY WITH SPECIFICATION REQUIREMENTS. DURING QUALITY ASSURANCE (QA) AND TECHNICAL ASSOCIATE (TA) CHECKS, NO ISSUES OF MISSING ADDITIVE TUBES WERE FOUND. 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.

    Additional Manufacturer Narrative · 0

    (B)(6). 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 · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES, THE DEVICE EXPERIENCED POOR BARRIER SEPARATION, INSUFFICIENT ADDITIVE QUANTITY, AND MISSING ADDITIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: IT WAS REPORTED BY THE CUSTOMER THAT THE SAMPLES DID NOT SEPARATE CORRECTLY WHEN THEY WERE SPUN. DEVICE NAME/DESCRIPTION: TUBE BLOOD COLLECTION VACUTAINER GOLD WITH CLOT ACTIVATOR AND GEL FOR SERUM ADDITIVE13MM X 75MM X 3.5ML CUSTOMER REPORTED SOME TUBES FROM LOT# 216703 MAY HAVE BEEN MISSING THE ADDITIVE THUS CAUSING A NON-CLOTTING ISSUE. CUSTOMER REPORTED TUBES FROM LOT# 216703 NOT CLOTTING AS EXPECTED. CUSTOMER REPORTS SOME OF THE TUBES APPEAR "COMPLETELY CLEAR OPPOSED TO THE MAJORITY OF THEM THAT HAD SPECKLES IN THEM".

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES, THE DEVICE EXPERIENCED POOR BARRIER SEPARATION, INSUFFICIENT ADDITIVE QUANTITY, AND MISSING ADDITIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: IT WAS REPORTED BY THE CUSTOMER THAT THE SAMPLES DID NOT SEPARATE CORRECTLY WHEN THEY WERE SPUN. DEVICE NAME/DESCRIPTION: TUBE BLOOD COLLECTION VACUTAINER GOLD WITH CLOT ACTIVATOR AND GEL FOR SERUM ADDITIVE13MM X 75MM X 3.5ML CUSTOMER REPORTED SOME TUBES FROM LOT# 216703 MAY HAVE BEEN MISSING THE ADDITIVE THUS CAUSING A NON-CLOTTING ISSUE. CUSTOMER REPORTED TUBES FROM LOT# 216703 NOT CLOTTING AS EXPECTED. CUSTOMER REPORTS SOME OF THE TUBES APPEAR "COMPLETELY CLEAR OPPOSED TO THE MAJORITY OF THEM THAT HAD SPECKLES IN THEM".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    186303 BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) 2161703 00382903679867

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown