BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 19466927 · Received June 5, 2024

    Report

    Report Number
    3003916417-2024-00145
    Event Type
    Malfunction
    Date Received
    June 5, 2024
    Date of Event
    May 6, 2024
    Report Date
    July 8, 2024
    Manufacturer
    BECTON DICKINSON IND. CIRURGICAS LTDA
    Product Code
    JKA
    UDI-DI
    30382903600572
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELD WAS UPDATED DUE TO A CORRECTION: F11: IMDRF ANNEX A GRID CODE: A0407 - MATERIAL DISCOLORED (1170). INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES, BUT 1 PHOTO WAS PROVIDED FOR INVESTIGATION. THE PHOTO WAS REVIEWED AND NO DEFECTS WERE OBSERVED. ADDITIONALLY, 200 RETENTION SAMPLES FROM BD INVENTORY WERE VISUALLY INSPECTED WITH NO ISSUES OBSERVED. 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. THIS COMPLAINT IS UNABLE TO BE CONFIRMED FOR THE INDICATED FAILURE MODES ADDITIVE ABNORMALITY, OTHER HARM. BASED ON THE INFORMATION PROVIDED, THE TUBES ARE BEING USED OUTSIDE OF PRODUCT CLAIMS. PER THE PACKAGE INSERT: "ENDOTOXIN NOT CONTROLLED. BLOOD AND BLOOD COMPONENTS COLLECTED AND PROCESSED IN THE TUBE ARE NOT INTENDED FOR INFUSION OR INTRODUCTION INTO THE HUMAN BODY." COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    MATERIAL #:305196 BATCH#: 4031363. IT WAS REPORTED BY CUSTOMER THAT CUST (B)(6) REPORTS THEY HAD 18G NEEDLES (B-D305196Z) CAUSING THE RUBBER STOPPERS ON VIALS TO CORE. CUST HAS SET ASIDE 14 BX FROM LOT # 4031363 WITH THIS ISSUE. CUST IS REQUESTING CREDIT AND CAN SEND BACK THE AFFECTED LOT. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. INJURIES OR ADVERSE EVENT: NO. MEDLINE REFERENCE #: (B)(4). ITEM: 305196 QUANTITY AFFECTED: (B)(4) BX. SERIAL/LOT NUMBER: (B)(6) . PO #: (B)(4). ARE ANY SAMPLES AVAILABLE FOR RETURN? YES. REPORTED ISSUE PER CUSTOMER: CUST (B)(6) REPORTS THEY HAD 18G NEEDLES (B-D305196Z). CAUSING THE RUBBER STOPPERS ON VIALS TO CORE. CUST HAS SET ASIDE 14 BX FROM LOT # 4031363 WITH THIS ISSUE. CUST IS REQUESTING CREDIT AND CAN SEND BACK THE AFFECTED LOT.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD VACUTAINER® K2 EDTA (K2E) 7.2MG BLOOD COLLECTION TUBES 100 TUBES CONTAINED DRY /ABNORMAL ADDITIVE. AN UNSPECIFIED NUMBER OF PATIENTS RECEIVING PLATELET RICH PLASMA REPORTED PAIN, IRRITATION, INFLAMMATION, AND BRUISES DURING AND AFTER THE PROCESS. THERE WAS NO OTHER HEALTH IMPACT OR CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    854871 BD VACUTAINER® K2 EDTA (K2E) 7.2MG BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON DICKINSON IND. CIRURGICAS LTDA 3119668 30382903600572

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown