BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBE

    MDR report key: 15221500 · Received August 12, 2022

    Report

    Report Number
    9617032-2022-00762
    Event Type
    Malfunction
    Date Received
    August 12, 2022
    Date of Event
    July 20, 2022
    Report Date
    September 12, 2022
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    PMA / PMN Number
    BK050036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1309955, MEDICAL DEVICE EXPIRATION DATE: 2023-04-30, DEVICE MANUFACTURE DATE: 2021-11-05. MEDICAL DEVICE LOT #: 2094463, MEDICAL DEVICE EXPIRATION DATE: 2023-09-30, DEVICE MANUFACTURE DATE: 2022-04-04. MEDICAL DEVICE LOT #: 1320310, MEDICAL DEVICE EXPIRATION DATE: 2023-05-31, DEVICE MANUFACTURE DATE: 2021-11-16. MEDICAL DEVICE LOT #: 2040913, MEDICAL DEVICE EXPIRATION DATE: 2023-08-31, DEVICE MANUFACTURE DATE: 2022-02-09. 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 ERRONEOUS RESULTS WERE OBSERVED. THERE WERE NO DIFFICULTIES ENCOUNTERED DURING BLOOD COLLECTION AND ALL TUBES APPEARED TO EXHIBIT PROPER FILL. BD WAS UNABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE, ERRONEOUS RESULTS, BECAUSE THE DEFECT WAS NOT EVIDENT IN THE TESTING OF THE COMPLAINT LOT SAMPLES. REPLICATES OF BOTH RETAIN AND CONTROL SAMPLES WERE ACCEPTABLE IN TERMS OF BOTH PRECISION AND ACCURACY. ALL VISUAL OBSERVATIONS OF BOTH RETAIN AND CONTROL SAMPLES TESTED DEMONSTRATED CLINICALLY ACCEPTABLE PERFORMANCE. 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 ERRONEOUS RESULTS. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. FACTORS THAT MAY CONTRIBUTE TO ERRONEOUS RESULTS 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® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBE THERE WAS ERRONEOUS RESULTS. THIS EVENT OCCURRED 400 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "WE PREDOMINANTLY USE VACUTAINER SST II ADVANCE BLOOD TUBES. GENERAL PRACTITIONERS HAVE REPORTED FALSELY ELEVATED PHOSPHATE RESULTS. THE ISSUE APPEARS TO BE PREVALENT. PRELIMINARY INVESTIGATIONS HAVE RULED OUT AN ANALYTICAL ISSUE. PHOSPHATE RESULTS ARE REPRODUCIBLE USING DIFFERENT MEASURING SYSTEMS. INSTRUMENT HARDWARE CHECKS USED TO DETECT REAGENT CARRIER FROM ON-BOARD REAGENTS CONTAINING PHOSPHATE BUFFERS HAVE RETURNED FAVORABLY. ELEVATED PHOSPHATE RESULTS ARE NOT ASSOCIATED WITH ELEVATED POTASSIUM RESULTS, AN INDICATION OF DELAYED SEPARATION. THE ELEVATION OF PHOSPHATE IS CONSISTENT ACROSS PATIENTS APPROXIMATELY +1MMOL/L. SO FAR AFFECTED PATIENTS HAVE BEEN ISOLATED TO THE FOLLOWING LOT NUMBERS OF TUBES; (B)(6)."

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBE THERE WAS ERRONEOUS RESULTS. THIS EVENT OCCURRED 400 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "WE PREDOMINANTLY USE VACUTAINER SST II ADVANCE BLOOD TUBES. GENERAL PRACTITIONERS HAVE REPORTED FALSELY ELEVATED PHOSPHATE RESULTS. THE ISSUE APPEARS TO BE PREVALENT. PRELIMINARY INVESTIGATIONS HAVE RULED OUT AN ANALYTICAL ISSUE. PHOSPHATE RESULTS ARE REPRODUCIBLE USING DIFFERENT MEASURING SYSTEMS. INSTRUMENT HARDWARE CHECKS USED TO DETECT REAGENT CARRIER FROM ON-BOARD REAGENTS CONTAINING PHOSPHATE BUFFERS HAVE RETURNED FAVORABLY. ELEVATED PHOSPHATE RESULTS ARE NOT ASSOCIATED WITH ELEVATED POTASSIUM RESULTS, AN INDICATION OF DELAYED SEPARATION. THE ELEVATION OF PHOSPHATE IS CONSISTENT ACROSS PATIENTS APPROXIMATELY +1MMOL/L. SO FAR AFFECTED PATIENTS HAVE BEEN ISOLATED TO THE FOLLOWING LOT NUMBERS OF TUBES; 1309955, 2094463, 1320310, 2040913."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2848057 BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBE BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown