BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® K3E 5.4MG PLUS BLOOD COLLECTION TUBES

    MDR report key: 15575155 · Received October 11, 2022

    Report

    Report Number
    9617032-2022-01004
    Event Type
    Malfunction
    Date Received
    October 11, 2022
    Date of Event
    September 30, 2022
    Report Date
    December 8, 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

    H.6. INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR EVALUATION. THEREFORE, RETENTION SAMPLES OF THE INCIDENT LOT WERE SELECTED FROM BD INVENTORY FOR EVALUATION AND UPON COMPLETION, NO ISSUES RELATING TO CLOTTING WERE OBSERVED. THERE WERE NO DIFFICULTIES ENCOUNTERED DURING BLOOD COLLECTION AND ALL RETAINED TUBES APPEARED TO EXHIBIT PROPER FILL. BD WAS NOT ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE, CLOTTING/FIBRIN, BECAUSE THE DEFECT WAS NOT EVIDENT IN THE TESTING OF THE RETAINED LOT SAMPLES. 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 MODE CLOTTING. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. FACTORS THAT MAY CONTRIBUTE TO CLOTTING WERE EVALUATED THROUGH A CLINICAL STUDY TO VERIFY THE DESIGN OF THE DEVICE MET IT¿S INTENDED USE. THE RESULT OF THE STUDY SHOWED THAT THE DEVICE PERFORMED AS EXPECTED AND WE WERE UNABLE TO DETERMINE ANY EXTERNAL CONTRIBUTOR TO THIS REPORTED ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® K3E 5.4MG PLUS BLOOD COLLECTION TUBES THAT THE NURSES DON'T HAVE TIME TO FILL THE TUBE THAT THE BLOOD HAS ALREADY COAGULATED. 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 (B)(4), 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 5.4MG PLUS BLOOD COLLECTION TUBES THAT THE NURSES DON'T HAVE TIME TO FILL THE TUBE THAT THE BLOOD HAS ALREADY COAGULATED. 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
    2897714 BD VACUTAINER® K3E 5.4MG PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 2150168

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown