BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER K2E 10.8MG PLUS BLOOD COLLECTION TUBES

    MDR report key: 10483034 · Received September 2, 2020

    Report

    Report Number
    9617032-2020-00693
    Event Type
    Malfunction
    Date Received
    September 2, 2020
    Date of Event
    August 12, 2020
    Report Date
    September 10, 2020
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: BD HAD NOT RECEIVED SAMPLES, BUT 2 PHOTOS WERE PROVIDED FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE INDICATED FAILURE MODE FOR MIXED TUBES THE INCIDENT LOT WAS OBSERVED. BUT THE COMPLAINT CAN NOT BE CONFIRMED BECAUSE THE PRODUCT PCN 367756 LOT 0023671 HAS ALREADY BEEN SHIPPED FROM THE MANUFACTURING SITE BEFORE THE PCN 367950 LOT 0056963 WAS STARTED TO MANUFACTURE. 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 NON-CONFORMANCES DURING MANUFACTURING OF THE PRODUCT. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS A MIX OF PRODUCT WITH 1000 BD VACUTAINER® K2E 10.8MG PLUS BLOOD COLLECTION TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE ORDERED AND RECEIVED 1000 VACUTAINER EDTA K2 TUBE 6ML YELLOW ON 14.07/2020, WITHIN THE BOX THERE WERE 2 PACKS OF 100 OF ITEM CODE 367756 LEMON TOP ACD SOLUTION, APPROX 30 HAVE BEEN ISSUED OUT AND WE ARE TRYING TO RECALL THE ITEM FROM WARDS ETC.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A MIX OF PRODUCT WITH 1000 BD VACUTAINER® K2E 10.8MG PLUS BLOOD COLLECTION TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE ORDERED AND RECEIVED 1000 VACUTAINER EDTA K2 TUBE 6ML YELLOW ON 14.07/2020, WITHIN THE BOX THERE WERE 2 PACKS OF 100 OF ITEM CODE 367756 LEMON TOP ACD SOLUTION, APPROX 30 HAVE BEEN ISSUED OUT AND WE ARE TRYING TO RECALL THE ITEM FROM WARDS ETC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    950069 BD VACUTAINER K2E 10.8MG PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 0056963

    Patients

    Seq Age Sex Outcome Treatment
    1 Other