BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® BARRICOR¿ LH PLASMA BLOOD COLLECTION TUBES

    MDR report key: 17547465 · Received August 14, 2023

    Report

    Report Number
    9617032-2023-01090
    Event Type
    Malfunction
    Date Received
    August 14, 2023
    Date of Event
    August 2, 2023
    Report Date
    August 15, 2023
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3: DATE OF EVENT IS A DATE RANGE; THEREFORE, DATE OF EVENT HAS BEEN LISTED AS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR EVALUATION. 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. BD MAKES NO CLAIMS ON EXPIRED MATERIALS. THIS COMPLAINT IS UNABLE TO BE CONFIRMED FOR THE INDICATED FAILURE MODE EXPIRED PRODUCT. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD VACUTAINER® BARRICOR¿ LH PLASMA BLOOD COLLECTION TUBES, 90 TUBES WERE USED AFTER THE EXPIRATION DATE. NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE CUSTOMER USED BETWEEN 75 AND 90 EXPIRED TUBES FROM LOT 2033807 BETWEEN (B)(6) AND (B)(6) AND REPORTED THE TEST RESULTS. THEY ARE ASKING IF WE HAVE DATA SUPPORTING THE PERFORMANCE OF THESE EXPIRED TUBES AND THE IMPACT ON THE RESULTS REPORTED."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD VACUTAINER® BARRICOR¿ LH PLASMA BLOOD COLLECTION TUBES, 90 TUBES WERE USED AFTER THE EXPIRATION DATE. NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE CUSTOMER USED BETWEEN 75 AND 90 EXPIRED TUBES FROM LOT 2033807 BETWEEN JUNE 30TH AND JULY 27TH AND REPORTED THE TEST RESULTS. THEY ARE ASKING IF WE HAVE DATA SUPPORTING THE PERFORMANCE OF THESE EXPIRED TUBES AND THE IMPACT ON THE RESULTS REPORTED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    962578 BD VACUTAINER® BARRICOR¿ LH PLASMA BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 2033807

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown