BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® K3E 7.2MG PLUS BLOOD COLLECTION TUBES

    MDR report key: 15710937 · Received November 1, 2022

    Report

    Report Number
    9617032-2022-01083
    Event Type
    Malfunction
    Date Received
    November 1, 2022
    Date of Event
    October 18, 2022
    Report Date
    July 15, 2024
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: MAT: 368860, LOT: 2153613. BD RECEIVED ONE PHOTOGRAPH FROM THE CUSTOMER IN SUPPORT OF THIS COMPLAINT. THE PHOTO WAS EVALUATED AND THE ISSUE OF MISSING LABEL WAS OBSERVED. ADDITIONALLY, AN EVALUATION OF THE 100 RETAINED TUBES FROM THIS THE BD INVENTORY IDENTIFIED NO FURTHER EXAMPLES OF MISSING LABELS. BD WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE BASED ON THE PHOTOGRAPH PROVIDED. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. THE DEVICE HISTORY RECORDS WERE REVIEWED WITH NO ISSUES BEING IDENTIFIED. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESSES AND FINAL INSPECTIONS COMPLY WITH SPECIFICATION REQUIREMENTS. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITIONS 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 THE IDENTIFICATION OF EMERGING TRENDS.

    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. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® K3E 7.2MG PLUS BLOOD COLLECTION TUBES THERE WAS NO LABEL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "HAS TUBES NOT LISTED. ASKS HOW TO PROCEED FOR RETURN. URGENT."

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® K3E 7.2MG PLUS BLOOD COLLECTION TUBES THERE WAS NO LABEL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "HAS TUBES NOT LISTED. ASKS HOW TO PROCEED FOR RETURN. URGENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1058554 BD VACUTAINER® K3E 7.2MG PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 2153613

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown