BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® BARRICOR¿ LH PLASMA BLOOD COLLECTION TUBES

    MDR report key: 14416000 · Received May 17, 2022

    Report

    Report Number
    9617032-2022-00477
    Event Type
    Malfunction
    Date Received
    May 17, 2022
    Date of Event
    May 6, 2022
    Report Date
    August 11, 2022
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVAL YES, D9: RETURNED TO MANUFACTURER ON: 16-AUG-2022 H.6. INVESTIGATION SUMMARY: MATERIAL #: 365049 LOT/BATCH #: 2033806 BD RECEIVED 4 SAMPLES FOR INVESTIGATION. THE CUSTOMER SAMPLES WERE EVALUATED ALONG WITH RETENTION SAMPLES OF THE INCIDENT LOT SELECTED FROM BD INVENTORY. THE SAMPLES WERE TESTED AND NO ISSUES RELATING TO CLOTTING WERE OBSERVED. 10 RETAINED SAMPLES WERE ANALYZED FOR HEPARIN CONTENT; ALL WERE FOUND TO BE WITHIN SPECIFICATION. ADDITIONALLY, RETURN SAMPLES AND RETAIN SAMPLES WERE EVALUATED CLINICALLY, WITH NO ISSUES BEING IDENTIFIED. THERE WERE NO DIFFICULTIES ENCOUNTERED DURING BLOOD COLLECTION AND ALL TUBES APPEARED TO EXHIBIT PROPER FILL. BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE, CLOTTING, BECAUSE THE DEFECTS WERE NOT EVIDENT IN THE TESTING OF THE CONTROL, RETAINED OR RETURNED LOT SAMPLES. WHITE PARTICULATE MATTER WAS OBSERVED IN THE SAMPLES, WHICH IS A NORMAL OCCURRENCE OF CELLULAR DEBRIS. 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 IS UNABLE TO BE CONFIRMED FOR THE INDICATED FAILURE MODE CLOTTING. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. FACTORS THAT MAY CONTRIBUTE TO CLOTTING WERE EVALUATED THROUGH A CLINICAL STUDY TO VERIFY THE DESIGN OF THE DEVICE MET IT¿S INTENDED USE. THE RESULT OF THE STUDY SHOWED THAT THE DEVICE PERFORMED AS EXPECTED AND WE WERE UNABLE TO DETERMINE ANY EXTERNAL CONTRIBUTOR TO THIS REPORTED ISSUE. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® BARRICOR¿ LH PLASMA BLOOD COLLECTION TUBES, THE DEVICE EXPERIENCED CLOTTING/MICRO CLOTS/FIBRIN CLOTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: TEST TUBE BARRICOR PRODUCT N.365049 LOT 2033806 COAGULATES INAPPROPRIATELY.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® BARRICOR¿ LH PLASMA BLOOD COLLECTION TUBES, THE DEVICE EXPERIENCED CLOTTING/MICRO CLOTS/FIBRIN CLOTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "TEST TUBE BARRICOR PRODUCT N.365049 LOT 2033806 COAGULATES INAPPROPRIATELY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1836422 BD VACUTAINER® BARRICOR¿ LH PLASMA BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 2033806

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown