BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® K2E 7.2MG PLUS BLOOD COLLECTION TUBE

    MDR report key: 16014696 · Received December 20, 2022

    Report

    Report Number
    9617032-2022-01297
    Event Type
    Malfunction
    Date Received
    December 20, 2022
    Date of Event
    November 23, 2022
    Report Date
    January 10, 2023
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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. 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: BD RECEIVED A PHOTO OF THE TUBE FILLED WITH WATER FROM THE CUSTOMER IN SUPPORT OF THIS COMPLAINT. THE PHOTO WAS EVALUATED AND THE ISSUE OF EXCESSIVE SOLUTION WAS OBSERVED. ADDITIONALLY, 100 RETAINED SAMPLES FROM THE BD INVENTORY WERE VISUALLY INSPECTED, AND NO DRAWN TUBES WERE FOUND. BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE WITH THE PHOTO PROVIDED. BD WAS NOT ABLE TO IDENTIFY THE EXACT 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.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® K2E 7.2MG PLUS BLOOD COLLECTION TUBE THERE WAS EXCESSIVE ADDITIVE QUANTITY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "WE HAVE A BOTTLE OF PURPLE TOP BLOOD COLLECTION VACUTAINER WHICH HAS SOLUTION IN APPROX. 3ML."

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® K2E 7.2MG PLUS BLOOD COLLECTION TUBE THERE WAS EXCESSIVE ADDITIVE QUANTITY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "WE HAVE A BOTTLE OF PURPLE TOP BLOOD COLLECTION VACUTAINER WHICH HAS SOLUTION IN APPROX. 3ML."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2597471 BD VACUTAINER® K2E 7.2MG PLUS BLOOD COLLECTION TUBE BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 1308992

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown