BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® K2 EDTA (K2E) PLUS BLOOD COLLECTION TUBES

    MDR report key: 16075123 · Received December 29, 2022

    Report

    Report Number
    9617032-2022-01338
    Event Type
    Malfunction
    Date Received
    December 29, 2022
    Date of Event
    December 2, 2022
    Report Date
    December 16, 2022
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    UDI-DI
    50382903666435
    PMA / PMN Number
    BK050036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: "BD DID NOT RECEIVE SAMPLES OR PHOTOGRAPHS FROM THE CUSTOMER IN SUPPORT OF THIS COMPLAINT. THEREFORE, 100 RETAINED SAMPLES FROM EACH LOT NUMBER PROVIDED WERE TAKEN AND VISUALLY INSPECTED, AND THE ISSUE OF CONDENSATION WAS NOT OBSERVED DURING THE INSPECTION. BD WAS UNABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE. 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." . THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 2150173, MEDICAL DEVICE EXPIRATION DATE: 2023-06-30, DEVICE MANUFACTURE DATE: 2022-05-30. MEDICAL DEVICE LOT #: 2122569, MEDICAL DEVICE EXPIRATION DATE: 2023-05-31, DEVICE MANUFACTURE DATE: 2022-05-02. MEDICAL DEVICE LOT #: 2130342, MEDICAL DEVICE EXPIRATION DATE: 2023-05-31, DEVICE MANUFACTURE DATE: 2022-05-10.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® K2 EDTA (K2E) PLUS BLOOD COLLECTION TUBES CUSTOMER HAS FOUND CONDENSATION INSIDE THE TUBE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "CUSTOMER REPORTS THAT THERE IS CONDENSATION INSIDE THE TUBE FOR ITEM 366643, LOT NO. 2150173, 2122569, 2130342. ALL PRODUCT WAS STORED IN THEIR CLIMATE CONTROLLED AREA OF THE WAREHOUSE. CUSTOMER NEEDS CONFIRMATION IF PRODUCT CAN STILL BE USED AND IS INQUIRING ON WHAT MAY HAVE CAUSED THE ISSUE.".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2240299 BD VACUTAINER® K2 EDTA (K2E) PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 366643 2130342 50382903666435

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown