BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® NO ADDITIVE (Z) TUBES

    MDR report key: 17500105 · Received August 10, 2023

    Report

    Report Number
    1917413-2023-00768
    Event Type
    Malfunction
    Date Received
    August 10, 2023
    Date of Event
    July 21, 2023
    Report Date
    August 30, 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

    B.1 DATE OF EVENT WAS UPDATED TO 21JUL2023. THE FOLLOWING LOTS ARE BEING TAKEN OUT OF PREVIOUSLY SUBMITTED REPORT 1917413-2023-00768, THESE LOTS OCCURRED AT SEPARATE LOCATIONS AND REQUIRE THEIR OWN COMPLAINT. D4. MEDICAL DEVICE LOT #: 3111788; D4. MEDICAL DEVICE EXPIRATION DATE: 2024-10-31; H4. DEVICE MANUFACTURE DATE: 2023-04-21. D4. MEDICAL DEVICE LOT #: 3048751; D4. MEDICAL DEVICE EXPIRATION DATE: 2024-08-31; H4. DEVICE MANUFACTURE DATE: 2023-02-17. H.6 INVESTIGATION SUMMARY: MATERIAL #: 366703; LOT/BATCH #: 2227106. BD HAD NOT RECEIVED SAMPLES, BUT 2 PHOTOS WERE PROVIDED FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE INDICATED FAILURE MODE FOR EMBEDDED FOREIGN MATTER WAS OBSERVED. EMBEDDED FM IS, BY ITS NATURE, ISOLATED FROM ANY SPECIMEN. 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 EMBEDDED 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

    E.6 INITIAL REPORTER E-MAIL: (B)(6). THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH ADDITIONAL LOT NUMBER IS AS FOLLOWS: D4. MEDICAL DEVICE LOT #: 3048751, D4. MEDICAL DEVICE EXPIRATION DATE: 2024-08-31, H4. DEVICE MANUFACTURE DATE: 2023-02-17. D4. MEDICAL DEVICE LOT #: 2227106, D4. MEDICAL DEVICE EXPIRATION DATE: 2024-02-29, H4. DEVICE MANUFACTURE DATE: 2022-08-15. D4. MEDICAL DEVICE LOT #: 3111788, D4. MEDICAL DEVICE EXPIRATION DATE: 2024-10-31, H4. DEVICE MANUFACTURE DATE: 2023-04-21. 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 THAT WHILE USING BD VACUTAINER® NO ADDITIVE (Z) TUBES THAT THERE WAS FOREIGN MATTER IN TUBE; BIOLOGICAL AND NON-BIOLOGICAL IN THREE DIFFERENT TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER IS REPORTING FOREIGN MATTER. AFFECTED LOT NUMBERS 3048751, 2227106, AND 3111788.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD VACUTAINER® NO ADDITIVE (Z) TUBES THAT THERE WAS FOREIGN MATTER IN TUBE; BIOLOGICAL AND NON-BIOLOGICAL IN THREE DIFFERENT TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER IS REPORTING FOREIGN MATTER. AFFECTED LOT NUMBERS 3048751, 2227106, AND 3111788.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1279551 BD VACUTAINER® NO ADDITIVE (Z) TUBES SPECIMEN TRANSPORT AND STORAGE CONTAINER FMH BECTON, DICKINSON & CO. (BROKEN BOW) SEE H.10 50382903667036

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown