BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® LH PST¿ II PLUS BLOOD COLLECTION TUBES

    MDR report key: 15201165 · Received August 10, 2022

    Report

    Report Number
    9617032-2022-00734
    Event Type
    Malfunction
    Date Received
    August 10, 2022
    Date of Event
    July 13, 2022
    Report Date
    August 18, 2022
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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 MATERIAL #: 367377, LOT/BATCH #: 2032146. BD HAD NOT RECEIVED SAMPLES, BUT 1 PHOTO WAS PROVIDED FOR INVESTIGATION. THE PHOTO WAS REVIEWED AND THE INDICATED FAILURE MODE FOR POOR BARRIER WAS NOT OBSERVED. ADDITIONALLY, RETENTION SAMPLES OF THE INCIDENT LOT WERE SELECTED FROM BD INVENTORY FOR EVALUATION AND UPON COMPLETION, NO ISSUES RELATING TO POOR BARRIER WERE OBSERVED. NO DIFFICULTIES WERE ENCOUNTERED DURING BLOOD COLLECTION AND ALL TUBES APPEARED TO EXHIBIT PROPER FILL. BD WAS UNABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE (POOR BARRIER) BECAUSE THE DEFECT WAS NOT EVIDENT IN THE TESTING OF THE COMPLAINT LOT SAMPLES. ALL SAMPLES (RETAIN AND CONTROL LOTS) DEMONSTRATED CLINICALLY ACCEPTABLE PERFORMANCE FOR ALL VISUAL OBSERVATIONS EVALUATED. ALL TUBES PERFORMED AS EXPECTED. 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 POOR BARRIER. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. FACTORS THAT MAY CONTRIBUTE TO POOR BARRIER 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. 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

    IT WAS REPORTED THAT BD VACUTAINER® LH PST¿ II PLUS BLOOD COLLECTION TUBES HAVE POOR SEPARATION BARRIER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PLASMA STILL BELOW GEL AFTER CENTRIFUGATION, CENTRIFUGE SPEED 3500RPM FOR 1 MINUTES.CENTRIFUGE USED HERAEUS MEGAFUGE 16".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD VACUTAINER® LH PST¿ II PLUS BLOOD COLLECTION TUBES HAVE POOR SEPARATION BARRIER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PLASMA STILL BELOW GEL AFTER CENTRIFUGATION CENTRIFUGE SPEED 3500RPM FOR 1 MINUTES. CENTRIFUGE USED HERAEUS MEGAFUGE 16.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1786581 BD VACUTAINER® LH PST¿ II PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 2032146

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown