BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® K3E PLUS BLOOD COLLECTION TUBES

    MDR report key: 15613178 · Received October 16, 2022

    Report

    Report Number
    9617032-2022-01031
    Event Type
    Malfunction
    Date Received
    October 16, 2022
    Date of Event
    September 30, 2022
    Report Date
    October 24, 2022
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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

    MFR REPORT # 9617032-2022-01031 IS TO BE CONSIDERED CANCELED. LOT # REPORTED WAS NOT INVOLVED. INCIDENT REPORTED ON MFR #: 9617032-2022-01004.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® K3E PLUS BLOOD COLLECTION TUBES WHEN THE NURSE FILL THE TUBE, IT COAGULATES QUICKLY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE EMERGENCY DEPARTMENT CALLED ME ABOUT THE EDTA K2 5ML/3ML TUBES REFERENCE 368856, LOT 2150168. IT SEEMS THAT THE NURSES DON'T HAVE TIME TO FILL THE TUBE THAT THE BLOOD HAS ALREADY COAGULATED. THIS PROBLEM DOES NOT OCCUR ON ALL TUBES AND I HAVE NOT HEARD FROM OTHER DEPARTMENTS."

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® K3E PLUS BLOOD COLLECTION TUBES WHEN THE NURSE FILL THE TUBE, IT COAGULATES QUICKLY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE EMERGENCY DEPARTMENT CALLED ME ABOUT THE EDTA K2 5ML/3ML TUBES REFERENCE 368856, LOT 2150168. IT SEEMS THAT THE NURSES DON'T HAVE TIME TO FILL THE TUBE THAT THE BLOOD HAS ALREADY COAGULATED. THIS PROBLEM DOES NOT OCCUR ON ALL TUBES AND I HAVE NOT HEARD FROM OTHER DEPARTMENTS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2175936 BD VACUTAINER® K3E PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 2227721

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown