BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® K2 EDTA (K2E) 7.2MG BLOOD COLLECTION TUBES

    MDR report key: 18779299 · Received February 26, 2024

    Report

    Report Number
    1917413-2024-00134
    Event Type
    Malfunction
    Date Received
    February 26, 2024
    Date of Event
    February 22, 2024
    Report Date
    March 29, 2024
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    UDI-DI
    30382903678618
    PMA / PMN Number
    BK050036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: BD DID NOT RECEIVE SAMPLES BUT 1 PHOTO WAS RETURNED BY THE CUSTOMER IN SUPPORT OF THIS COMPLAINT FROM CATALOG 367861, LOT NUMBER 3163679. VISUAL EXAMINATION OF THE PHOTO WAS PERFORMED AND REVEALED IMPROPER ASSEMBLY CAUSING THE HEMOGARD CLOSURE TO NOT BE PLACED ON THE TUBE CORRECTLY. BD WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE WITH THE INVESTIGATION COMPLETED. THE EXACT CAUSE FOR THE CUSTOMER¿S FAILURE MODE COULD NOT BE DETERMINED. 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. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    B3: DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE MEDICAL DEVICE TYPES REPORTED TO BE INVOLVED. THE INFORMATION FOR THE ADDITIONAL DEVICE TYPE IS AS FOLLOWS: D2B:GIM THERE WERE MULTIPLE 510K NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR THE ADDITIONAL 510K IS AS FOLLOWS: G5. PMA / 510(K)#: K213670. H3. 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 BD VACUTAINER® K2 EDTA (K2E) 7.2MG BLOOD COLLECTION TUBES A STOPPER DEFECT WAS OBSERVED IN 4 TUBES. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "GREY STOPPER SEEMS TO BE MELTED OR CRUSHED ON THE ONE SIDE RESULTING IN THE CAPS NOT BEING SEATED ON THE TUBES CORRECTLY. THE CAPS ARE LOOSE AND THE TUBES CANNOT BE USED."

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING BD VACUTAINER® K2 EDTA (K2E) 7.2MG BLOOD COLLECTION TUBES A STOPPER DEFECT WAS OBSERVED IN 4 TUBES. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "GREY STOPPER SEEMS TO BE MELTED OR CRUSHED ON THE ONE SIDE RESULTING IN THE CAPS NOT BEING SEATED ON THE TUBES CORRECTLY. THE CAPS ARE LOOSE AND THE TUBES CANNOT BE USED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1932168 BD VACUTAINER® K2 EDTA (K2E) 7.2MG BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) 3163679 30382903678618

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown