BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® K2E (EDTA) 18.0MG PLUS BLOOD COLLECTION TUBE

    MDR report key: 15741574 · Received November 6, 2022

    Report

    Report Number
    9617032-2022-01102
    Event Type
    Malfunction
    Date Received
    November 6, 2022
    Date of Event
    October 19, 2022
    Report Date
    November 29, 2022
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: BD RECEIVED A PHOTOGRAPH FROM THE CUSTOMER IN SUPPORT OF THIS COMPLAINT. THE EVALUATION OF THE SHELF PACK LABEL IN THE PHOTOGRAPH WAS IDENTICAL COMPARED WITH THE RETAINED SAMPLES OF THE BD INVENTORY. BD WAS UNABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE BASED ON THE VISUAL CHECK OF RETAINED SAMPLES. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. A COMPLAINT HISTORY REVIEW WAS CONDUCTED AND ONLY THE CURRENT COMPLAINT WAS FOUND RELATING TO THE INCIDENT LOT NUMBER 1245679 AND THE ¿AS REPORTED¿ DEFECT CODE. 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.

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® K2E (EDTA) 18.0MG PLUS BLOOD COLLECTION TUBE THE TUBE WAS USED AFTER THE EXPIRATION DATE." THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "WE HAVE BEEN WORKING IN MEDICAL GENETICS AND USING BD VACUTAINER AND OTHER PRODUCTS FOR THE LAST 20 YEARS. CURRENTLY, WE ARE FACING A HUGE PROBLEM AS SUPPLIERS ARE PROVIDING US FAKE/EXPIRED BD VACUTAINER WITH RE-LABELLING AS WELL SYRINGES DUE TO WHICH WE LOST A LOT OF OUR PRECIOUS BLOOD SAMPLES."

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® K2E (EDTA) 18.0MG PLUS BLOOD COLLECTION TUBE THE TUBE WAS USED AFTER THE EXPIRATION DATE." THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "WE HAVE BEEN WORKING IN MEDICAL GENETICS AND USING BD VACUTAINER AND OTHER PRODUCTS FOR THE LAST 20 YEARS. CURRENTLY, WE ARE FACING A HUGE PROBLEM AS SUPPLIERS ARE PROVIDING US FAKE/EXPIRED BD VACUTAINER WITH RE-LABELLING AS WELL SYRINGES DUE TO WHICH WE LOST A LOT OF OUR PRECIOUS BLOOD SAMPLES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2852798 BD VACUTAINER® K2E (EDTA) 18.0MG PLUS BLOOD COLLECTION TUBE BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 1245679

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown