BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER SERUM BLOOD COLLECTION TUBES

    MDR report key: 12013363 · Received June 16, 2021

    Report

    Report Number
    1024879-2021-00396
    Event Type
    Malfunction
    Date Received
    June 16, 2021
    Date of Event
    December 29, 2021
    Report Date
    May 26, 2021
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    50382903678124
    PMA / PMN Number
    BK050036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR INVESTIGATION OF MATERIAL # 367812, BATCH # 0100893. THEREFORE, 29 RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY VISUAL EXAMINATION AND STOPPER PULL OUT TESTING. THREE (3) OUT OF THE 29 SAMPLES FAILED THE STOPPER PULL OUT TESTING AND THE ISSUE RELATING TO STOPPER POP OFF WAS OBSERVED. 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. BD HAS INITIATED FURTHER ROOT CAUSE INVESTIGATION RELATING TO THE ISSUE OF STOPPER POP OFF THROUGH CORRECTIVE AND PREVENTIVE ACTIONS. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® SERUM BLOOD COLLECTION TUBES, THE DEVICE EXPERIENCED STOPPER POPPING OUT OF THE TUBE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: VERBIAGE RECEIVED, - "I HAVE A FEW DEPARTMENTS IN THE HOSPITAL COMPLAINING ABOUT SOME VACUTAINER BLOOD COLLECTION TUBES 4ML RED TOPS HAVING ISSUES WITH THE CAPS STAYING ON."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    905929 BD VACUTAINER SERUM BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) 367812 0100893 50382903678124

    Patients

    Seq Age Sex Outcome Treatment
    1