BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® GLASS CPT MOLECULAR DIAGNOSTICS TUBE

    MDR report key: 7110260 · Received December 12, 2017

    Report

    Report Number
    1917413-2017-00588
    Event Type
    Malfunction
    Date Received
    December 12, 2017
    Date of Event
    November 21, 2017
    Report Date
    January 23, 2018
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    JKA
    UDI-DI
    50382903627610
    PMA / PMN Number
    K911731
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    BD RECEIVED SAMPLES FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE SAMPLES WERE VISUALLY EVALUATED AND NO ISSUES PERTAINING TO DEFECTS WITH THE TUBE GLASS WAS OBSERVED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR THE INCIDENT LOT AND, BASED ON THIS REVIEW, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET; THERE WERE NO RELATED QUALITY NON-CONFORMANCES DURING MANUFACTURING OF THE PRODUCT. BASED ON EVALUATION OF THE CUSTOMER SAMPLES, THE CUSTOMER¿S INDICATED FAILURE MODE FOR GLASS BREAKAGE WITH THE INCIDENT LOT WAS NOT OBSERVED AS ALL SAMPLES MET THE REQUIRED SPECIFICATIONS. BASED ON THE INVESTIGATION, A ROOT CAUSE COULD NOT BE DETERMINED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. THE BD BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Additional Manufacturer Narrative · 1

    DATE RECEIVED BY MANUFACTURING: CHANGED/CORRECTED FROM 11/21/2107 TO 11/21/2017.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING USE OF THE BD VACUTAINER® GLASS CPT MOLECULAR DIAGNOSTICS TUBE THAT TWO OF THE TUBES BROKE IN OUR CENTRIFUGE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    890504 BD VACUTAINER® GLASS CPT MOLECULAR DIAGNOSTICS TUBE BLOOD COLLECTION TUBE JKA BECTON, DICKINSON & CO. 7143947 50382903627610

    Patients

    Seq Age Sex Outcome Treatment
    1 Other