BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® K2 EDTA (K2E) 3.6MG BLOOD COLLECTION TUBE

    MDR report key: 15596912 · Received October 13, 2022

    Report

    Report Number
    1917413-2022-00644
    Event Type
    Malfunction
    Date Received
    October 13, 2022
    Date of Event
    October 4, 2022
    Report Date
    October 18, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    UDI-DI
    50382903678414
    PMA / PMN Number
    BK050036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    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

    H.6. INVESTIGATION SUMMARY: NO SAMPLES AND 1 PHOTO WERE RETURNED BY THE CUSTOMER IN SUPPORT OF THIS COMPLAINT FROM CATALOG 367841, LOT NUMBER 2080642. A VISUAL EXAMINATION OF THE PHOTO WAS PERFORMED AND THE ISSUE OF IMPROPER ASSEMBLY (UNCAPPED) WAS OBSERVED. ADDITIONALLY, 86 RETENTION SAMPLES FROM THE BD INVENTORY WERE INSPECTED WITH NO ISSUES BEING IDENTIFIED. BD WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE WITH THE PHOTO PROVIDED. THE EXACT CAUSE FOR THE CUSTOMER¿S FAILURE MODE COULD NOT BE DETERMINED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® K2 EDTA (K2E) 3.6MG BLOOD COLLECTION TUBE THERE WAS A STERILITY ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "WHILE DOING LABELING, WE FOUND 1 BOX OF 367841 WITH 1 PC INSIDE UNCAPPED."

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® K2 EDTA (K2E) 3.6MG BLOOD COLLECTION TUBE THERE WAS A STERILITY ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "WHILE DOING LABELING, WE FOUND 1 BOX OF 367841 WITH 1 PC INSIDE UNCAPPED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2271740 BD VACUTAINER® K2 EDTA (K2E) 3.6MG BLOOD COLLECTION TUBE BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) 367841 2080642 50382903678414

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown