BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® NO ADDITIVE (Z) TUBES

    MDR report key: 15541834 · Received October 5, 2022

    Report

    Report Number
    1024879-2022-00549
    Event Type
    Malfunction
    Date Received
    October 5, 2022
    Date of Event
    September 10, 2022
    Report Date
    July 15, 2024
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    FMH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 HAVE BEEN UPDATED WITH CORRECTED AND/OR ADDITIONAL INFORMATION. D9: DEVICE AVAILABLE FOR EVALUATION: YES; D9: RETURNED TO MANUFACTURER ON: 19-SEPT-2022. INVESTIGATION SUMMARY: CATALOG NUMBER: 366702; BATCH NUMBER: 2153707. BD RECEIVED 119 SAMPLES AND 3 PHOTOS FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE CUSTOMER¿S INDICATED FAILURE MODE FOR FOREIGN MATTER WAS OBSERVED. ADDITIONALLY, 30 OF THE 119 CUSTOMER SAMPLES WERE RANDOMLY SELECTED AND WERE SUBJECTED TO A VISUAL INSPECTION FOR FM. 17 OF THE 30 CUSTOMER SAMPLES FAILED. OUT OF THE FAILURES, 15 WERE EMBEDDED FM, 1 WAS FM-DIRT WITHIN THE TUBE, AND THE LAST FAILURE WAS FM-NONBIOLOGIC (RED PLASTIC) THAT WAS FOUND ON THE OUTSIDE OF THE TUBE UNDER THE LABEL. 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 DETERMINED THAT THE ROOT CAUSE OF THE INDICATED FAILURE MODE WAS ATTRIBUTED TO THE PREVENTATIVE MAINTENANCE WITHIN THE MANUFACTURING PROCESS. 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® NO ADDITIVE (Z) TUBES THERE WAS FOREIGN MATTER IN THE TUBE(S) BIOLOGICAL AND NON-BIOLOGICAL. THIS EVENT OCCURRED 16 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THERE ARE BLACK SPECKS ON OR EMBEDDED IN THE PLASTIC OF THE TUBES.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® NO ADDITIVE (Z) TUBES THERE WAS FOREIGN MATTER IN THE TUBE(S) BIOLOGICAL AND NON-BIOLOGICAL. THIS EVENT OCCURRED 16 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THERE ARE BLACK SPECKS ON OR EMBEDDED IN THE PLASTIC OF THE TUBES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2556045 BD VACUTAINER® NO ADDITIVE (Z) TUBES SPECIMEN TRANSPORT AND STORAGE CONTAINER FMH BECTON, DICKINSON & CO., (BD) 2153707

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown