BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® K2 EDTA (K2E) 10.8MG BLOOD COLLECTION TUBES

    MDR report key: 16854142 · Received May 2, 2023

    Report

    Report Number
    1917413-2023-00361
    Event Type
    Malfunction
    Date Received
    May 2, 2023
    Date of Event
    April 11, 2023
    Report Date
    May 3, 2023
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    UDI-DI
    50382903678995
    PMA / PMN Number
    BK980011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. 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 HAD NOT RECEIVED SAMPLES, BUT [2] PHOTOS WERE PROVIDED FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND VISUALLY EXAMINED AND THE INDICATED FAILURE MODE FOR FOREIGN MATTER -FM WAS OBSERVED ON THE INSIDE OF THE TUBE. THERE APPEARS TO BE A RED, BLOOD LIKE SUBSTANCE IN THE TUBE. THE SAMPLE WAS NOT RETURNED; THEREFORE, THE INVESTIGATION WAS LIMITED. BD WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE WITH THE PHOTOS PROVIDED. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOT, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THERE WERE NO RELATED QUALITY ISSUES DURING MANUFACTURING OF THE PRODUCT. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE." H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® K2 EDTA (K2E) 10.8MG BLOOD COLLECTION TUBE THERE WAS FOREIGN MATTER IN THE TUBE(S) BIOLOGICAL AND NON-BIOLOGICAL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "ONE TUBE OUT OF 100 FROM A BOX OF EDTA TUBES CATALOG 367899 ,LOT# 2132110 APPEARED TO HAVE A SPLASH OF BLOOD IN IT AT THE BOTTOM OF THE TUBE."

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® K2 EDTA (K2E) 10.8MG BLOOD COLLECTION TUBE THERE WAS FOREIGN MATTER IN THE TUBE(S) BIOLOGICAL AND NON-BIOLOGICAL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "ONE TUBE OUT OF 100 FROM A BOX OF EDTA TUBES CATALOG 367899 LOT# 2132110 APPEARED TO HAVE A SPLASH OF BLOOD IN IT AT THE BOTTOM OF THE TUBE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1533424 BD VACUTAINER® K2 EDTA (K2E) 10.8MG BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) 367899 2132110 50382903678995

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown