BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SERUM BLOOD COLLECTION TUBES

    MDR report key: 14920769 · Received July 5, 2022

    Report

    Report Number
    1024879-2022-00334
    Event Type
    Malfunction
    Date Received
    July 5, 2022
    Date of Event
    June 6, 2022
    Report Date
    August 8, 2022
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    50382903678124
    PMA / PMN Number
    BK050036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. DEVICE EVALUATED BY MFR: A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY CATALOG NUMBER: 367812 BATCH NUMBER: 1252940 THE DEVICE HISTORY RECORD WAS REVIEWED WITH NO ISSUES BEING IDENTIFIED. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESS AND FINAL INSPECTIONS COMPLY WITH SPECIFICATION REQUIREMENTS. NO CUSTOMER SAMPLES OR PHOTOS WERE RECEIVED FOR REVIEW AND ANALYSIS OF DAMAGED RUBBER SEAL 30 RETENTION SAMPLES WERE SUBJECTED TO A VISUAL TEST FOR DAMAGED PRODUCT/COMPONENT (DAMAGED STOPPER). 0 OF 30 SAMPLES FAILED THE TEST FOR DAMAGED PRODUCT/COMPONENT (DAMAGED STOPPER). THEREFORE, THIS COMPLAINT IS NOT CONFIRMED BASED ON RETENTION SAMPLE TESTING. THEREFORE, BD IS NOT ABLE TO CONFIRM THE CUSTOMERS REPORTED FAILURE MODE OF DAMAGED PRODUCT/COMPONENT (DAMAGED STOPPER) WITH THE RETAIN SAMPLE TEST RESULTS. BASED ON A REVIEW OF BATCH RECORDS AND THE INVESTIGATION RESULTS, NO ROOT CAUSE FROM THE MANUFACTURING PROCESS HAS BEEN IDENTIFIED AS A CONTRIBUTOR. 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® SERUM BLOOD COLLECTION TUBE THE RUBBER SEAL WAS DAMAGED. THIS EVENT OCCURRED 3 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "DAMAGED RUBBER SEAL."

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® SERUM BLOOD COLLECTION TUBE THE RUBBER SEAL WAS DAMAGED. THIS EVENT OCCURRED 3 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "DAMAGED RUBBER SEAL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1481009 BD VACUTAINER® SERUM BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) 367812 1252940 50382903678124

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown