BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® EDTA 2K

    MDR report key: 15450755 · Received September 19, 2022

    Report

    Report Number
    1917413-2022-00582
    Event Type
    Malfunction
    Date Received
    September 19, 2022
    Date of Event
    September 6, 2022
    Report Date
    October 5, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    PMA / PMN Number
    K981013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVALUATION: YES. D9: RETURNED TO MANUFACTURER ON: 2022-10-04. H.6. INVESTIGATION SUMMARY: MAT: 367846. LOT: 1350324. BD RECEIVED (B)(4) SAMPLES AND 2 PHOTOS FROM THE CUSTOMER IN SUPPORT OF THIS COMPLAINT. A VISUAL EXAMINATION OF SAMPLES AND PHOTOS WAS PERFORMED AND REVEALED THAT THE LABELS APPLIED ARE FUKUSHIMA LABELS USED FOR INSPECTED PRODUCT. THESE LABELS ARE NOT APPLIED AT THE MANUFACTURING SITE. THE RETENTION SHELF LABEL WAS INSPECTED WITH NO ISSUES. BD WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE WITH THE SAMPLES AND PHOTOS PROVIDED. 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. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® EDTA 2K THERE WAS A LABEL ISSUE/PROBLEM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "A RECTANGLE LABEL IS USUALLY AFFIXED TO THE FILM PACKAGE BUT A SQUARE LABEL WAS AFFIXED TO THE FILM PACKAGE."

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® EDTA 2K THERE WAS A LABEL ISSUE/PROBLEM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "A RECTANGLE LABEL IS USUALLY AFFIXED TO THE FILM PACKAGE BUT A SQUARE LABEL WAS AFFIXED TO THE FILM PACKAGE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124849 BD VACUTAINER® EDTA 2K BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) 1350324

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown