BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® K2 EDTA (K2E) 3.6MG BLOOD COLLECTION TUBES

    MDR report key: 18630966 · Received February 2, 2024

    Report

    Report Number
    1917413-2024-00074
    Event Type
    Malfunction
    Date Received
    February 2, 2024
    Date of Event
    January 9, 2024
    Report Date
    March 5, 2024
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    UDI-DI
    50382903678414
    PMA / PMN Number
    BK050036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 13-FEB-2024 H.6. INVESTIGATION SUMMARY: BD RECEIVED ONE SAMPLE AND TWO PHOTOS IN SUPPORT OF THIS COMPLAINT FROM CATALOG 367841, LOT NUMBER 3111799. VISUAL EXAMINATION OF THE SAMPLE AND PHOTOS WAS PERFORMED AND REVEALED DEFECTIVE STOPPER MOLDING AS THERE IS AN EXTRA STOPPER MATERIAL IN THE STOPPER WELL. BD WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE WITH THE INVESTIGATION COMPLETED. THE EXACT CAUSE FOR THE CUSTOMER¿S FAILURE MODE COULD NOT BE DETERMINED. THE DEVICE HISTORY RECORDS WERE REVIEWED WITH NO ISSUES BEING IDENTIFIED. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESS 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 IDENTIFICATION OF EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    E1. INITIAL REPORTER FACILITY NAME: (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 PRIOR TO USE THE BD VACUTAINER® K2 EDTA (K2E) 3.6MG BLOOD COLLECTION TUBES HAD A DEFORMED RUBBER STOPPER. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED PRIOR TO USE THE BD VACUTAINER® K2 EDTA (K2E) 3.6MG BLOOD COLLECTION TUBES HAD A DEFORMED RUBBER STOPPER. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1557849 BD VACUTAINER® K2 EDTA (K2E) 3.6MG BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) 3111799 50382903678414

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown