BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® K2E 3.6MG PLUS BLOOD COLLECTION TUBES

    MDR report key: 18584475 · Received January 25, 2024

    Report

    Report Number
    9617032-2024-00075
    Event Type
    Malfunction
    Date Received
    January 25, 2024
    Date of Event
    January 3, 2024
    Report Date
    February 8, 2024
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    UDI-DI
    30382903688419
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: BD DID NOT RECEIVE SAMPLES OR PHOTOGRAPHS FROM THE CUSTOMER IN SUPPORT OF THIS COMPLAINT. 10 RETAINED SAMPLES FROM LOT NUMBER 3170101, WERE TESTED AND NONE OF THE CAP/STOPPER ASSEMBLIES POPPED OFF. NO OBJECTIVE EVIDENCE WAS PROVIDED TO INDICATE THAT THE DEVICE WAS THE CAUSE OF THE REPORTED DEFECT. BD WAS UNABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE WITH THE RETAINED SAMPLES TEST RESULTS. NO DEFINITIVE ROOT CAUSE COULD BE ESTABLISHED FOR THE REPORTED DEFECT. THE DEVICE HISTORY RECORDS WERE REVIEWED WITH NO ISSUES BEING IDENTIFIED. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESSES AND FINAL INSPECTIONS COMPLY WITH SPECIFICATION REQUIREMENTS. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR THE IDENTIFICATION OF EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    E1: INITIAL REPORTER FACILITY NAME: (B)(6). INITIAL REPORTER PHONE #: (B)(6). H3: 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 BD VACUTAINER® K2E 3.6MG PLUS BLOOD COLLECTION TUBES THAT A STOPPER POPPED OFF AND THE TUBE WAS LODGED IN THE SMART BLOOD COLLECTION SYSTEM. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING BD VACUTAINER® K2E 3.6MG PLUS BLOOD COLLECTION TUBES THAT A STOPPER POPPED OFF AND THE TUBE WAS LODGED IN THE SMART BLOOD COLLECTION SYSTEM. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1899690 BD VACUTAINER® K2E 3.6MG PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 3170101 30382903688419

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown