BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® K2 EDTA (K2E) 7.2MG BLOOD COLLECTION TUBES

    MDR report key: 17830970 · Received September 28, 2023

    Report

    Report Number
    1917413-2023-00936
    Event Type
    Malfunction
    Date Received
    September 28, 2023
    Date of Event
    August 31, 2023
    Report Date
    January 4, 2024
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    UDI-DI
    50382903678612
    PMA / PMN Number
    BK050036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B5: INITIALLY WAS REPORTED AS 1 OF 2, IT IS 1 OF 1 REPORT. H.6. INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES BUT 1 VIDEO WAS RECEIVED FROM CATALOG 367861, LOT NUMBER 2132097. THE VIDEO WAS VISUALLY EVALUATED SHOWING THE AMOUNT DRAWN INTO THE TUBE IS BELOW THE FILL LINE ON THE TUBE LABEL. THE PRODUCT EXPIRED 30SEPT2023. 100 PRODUCTION LOT IN-HOUSE RETENTION SAMPLES WERE INSPECTED WITH 0 VISIBLE DEFECTS. A DRAW TEST WAS PERFORMED AT THE MANUFACTURING SITE ON 10 RETENTION SAMPLES. ALL TUBES WERE WITHIN SPECIFICATION LIMITS. 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

    H.3. 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 THAT WHILE USING THE BD VACUTAINER® K2 EDTA (K2E) 7.2MG BLOOD COLLECTION TUBES THAT THERE WAS UNDERFILL OR LOW BLOOD DRAW WITH A TUBE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE TUBES HAVE LOW VACUUM AND TAKE TOO LONG TO FILL.

    Description of Event or Problem · 0

    REPORT 1 OUT OF 2. IT WAS REPORTED THAT WHILE USING THE BD VACUTAINER® K2 EDTA (K2E) 7.2MG BLOOD COLLECTION TUBES THAT THERE WAS UNDERFILL OR LOW BLOOD DRAW WITH A TUBE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE TUBES HAVE LOW VACUUM AND TAKE TOO LONG TO FILL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1846524 BD VACUTAINER® K2 EDTA (K2E) 7.2MG BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) 2132097 50382903678612

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown