BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SODIUM HEPARIN (NH) BLOOD COLLECTION TUBES

    MDR report key: 19097049 · Received April 12, 2024

    Report

    Report Number
    1917413-2024-00307
    Event Type
    Malfunction
    Date Received
    April 12, 2024
    Date of Event
    March 18, 2024
    Report Date
    March 26, 2024
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    UDI-DI
    50382903678742
    PMA / PMN Number
    K944566
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES BUT ONE PHOTO WAS RETURNED BY THE CUSTOMER IN SUPPORT OF THIS COMPLAINT FOR CATALOG: 367874, LOT NUMBER: 3222743. VISUAL EXAMINATION OF THE PHOTO WAS PERFORMED AND REVEALED FM ON THE STOPPER. THERE ARE BROWN SPECKS ON THE EDGE OF THE STOPPER. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® SODIUM HEPARIN (NH) BLOOD COLLECTION TUBES THERE WAS A TUBE STOPPER WITH COLOR VARIATION. THERE WAS NO REPORT OF IMPACT TO THE PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1413111 BD VACUTAINER® SODIUM HEPARIN (NH) BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) 3222743 50382903678742

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown