BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® NO ADDITIVE (Z) TUBES

    MDR report key: 17514909 · Received August 11, 2023

    Report

    Report Number
    1917413-2023-00781
    Event Type
    Malfunction
    Date Received
    August 11, 2023
    Date of Event
    August 9, 2023
    Report Date
    September 28, 2023
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    FMH
    UDI-DI
    50382903667036
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: MATERIAL #: 366703. LOT/BATCH #: 3111788. BD HAD NOT RECEIVED SAMPLES, BUT 2 PHOTOS WERE PROVIDED FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE INDICATED FAILURE MODE FOR FOREIGN MATTER WAS OBSERVED. 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 THE INDICATED FAILURE MODE FOREIGN MATTER. 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.

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® NO ADDITIVE (Z) TUBES CUSTOMER FOUND FOREIGN MATTER INSIDE THE TUBE. THIS EVENT OCCURRED 6 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: CUSTOMER PROBLEM: CUSTOMER IS REPORTING FOREIGN MATTER. AFFECTED LOT NUMBER 3111788. RELATED TO CASE (B)(4) . STEPS TAKEN WITH CUSTOMER/TROUBLESHOOTING: CUSTOMER SENT EMAIL STATING THIS IS THE SECOND FACILITY CONFIRMED ON 8/9/2023. CLIENTS RECEIVED TUBES THAT HAD FOREIGN MATTER IN THE TUBES. THERE WAS NO PATIENT HARM. WHEN THEY SAW THAT THE TUBES HAD FOREIGN MATTER THEY USED DIFFERENT TUBES.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® NO ADDITIVE (Z) TUBES CUSTOMER FOUND FOREIGN MATTER INSIDE THE TUBE. THIS EVENT OCCURRED 6 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: CUSTOMER PROBLEM: CUSTOMER IS REPORTING FOREIGN MATTER. AFFECTED LOT NUMBER 3111788. RELATED TO CASE (B)(4). STEPS TAKEN WITH CUSTOMER/TROUBLESHOOTING: CUSTOMER SENT EMAIL STATING THIS IS THE SECOND FACILTIY CONFIRMED ON (B)(6) 2023. CLIENTS RECEIVED TUBES THAT HAD FOREIGN MATTER IN THE TUBES. THERE WAS NO PATIENT HARM. WHEN THEY SAW THAT THE TUBES HAD FOREIGN MATTER THEY USED DIFFERENT TUBES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    869780 BD VACUTAINER® NO ADDITIVE (Z) TUBES SPECIMEN TRANSPORT AND STORAGE CONTAINER FMH BECTON, DICKINSON & CO. (BROKEN BOW) 3111788 50382903667036

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown