BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER PPT PLASMA PREPARATION TUBE K2E

    MDR report key: 11697949 · Received April 20, 2021

    Report

    Report Number
    1917413-2021-00301
    Event Type
    Malfunction
    Date Received
    April 20, 2021
    Date of Event
    March 25, 2021
    Report Date
    June 21, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    PJE
    UDI-DI
    50382903627887
    PMA / PMN Number
    K972075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: BD HAD NOT RECEIVED SAMPLES, BUT 3 PHOTOS WERE PROVIDED FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE INDICATED FAILURE MODE FOR POOR PLASMA (AGGREGATES) WAS OBSERVED. ADDITIONALLY, RETENTION SAMPLES OF THE INCIDENT LOT WERE SELECTED FROM BD INVENTORY FOR EVALUATION AND UPON COMPLETION, NO ISSUES RELATING TO POOR PLASMA/AGGREGATES WERE OBSERVED. NO DIFFICULTIES WERE ENCOUNTERED DURING BLOOD COLLECTION AND ALL TUBES APPEARED TO EXHIBIT PROPER FILL. BD WAS UNABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (FIBRIN/FIBRIN MASS/CLOTS) BECAUSE THE DEFECT WAS NOT EVIDENT IN THE TESTING OF THE COMPLAINT LOT SAMPLES. EVALUATION OF BOTH RETAIN AND CONTROL SAMPLES TESTED WAS ACCEPTABLE. ALL SAMPLES DEMONSTRATED CLINICALLY ACCEPTABLE PERFORMANCE FOR ALL VISUAL OBSERVATIONS EVALUATED. 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. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THE BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E EXPERIENCED POOR BARRIER SEPARATION OF SAMPLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: ACCORDING TO THE TEACHER¿S FEEDBACK, AFTER CENTRIFUGATION OF THE SAMPLE RECENTLY, IT WAS FOUND THAT THERE WERE AGGREGATES IN THE PLASMA. THE SITUATION HAS BEEN SERIOUS RECENTLY, AND IT HAS MANY SHAPES, LARGE AND SMALL, WHICH EXIST IN ALMOST EVERY PPT TUBE, WHICH SERIOUSLY AFFECTS THE SUCTION OF THE MACHINE PROBE AND THE MACHINE FREQUENTLY ALARM , AND OPENED A NEW BOX OF PPT TUBE TO USE, AND FOUND THAT THE PROBLEM STILL EXISTS.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THE BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E EXPERIENCED POOR BARRIER SEPARATION OF SAMPLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: ACCORDING TO THE TEACHER¿S FEEDBACK, AFTER CENTRIFUGATION OF THE SAMPLE RECENTLY, IT WAS FOUND THAT THERE WERE AGGREGATES IN THE PLASMA. THE SITUATION HAS BEEN SERIOUS RECENTLY, AND IT HAS MANY SHAPES, LARGE AND SMALL, WHICH EXIST IN ALMOST EVERY PPT TUBE, WHICH SERIOUSLY AFFECTS THE SUCTION OF THE MACHINE PROBE AND THE MACHINE FREQUENTLY ALARM , AND OPENED A NEW BOX OF PPT TUBE TO USE, AND FOUND THAT THE PROBLEM STILL EXISTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    589561 BD VACUTAINER PPT PLASMA PREPARATION TUBE K2E BLOOD SPECIMEN COLLECTION DEVICE PJE BECTON, DICKINSON & CO. (BROKEN BOW) 362788 0133206 50382903627887

    Patients

    Seq Age Sex Outcome Treatment
    1