BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) BLOOD COLLECTION TUBES

    MDR report key: 14437999 · Received May 19, 2022

    Report

    Report Number
    1917413-2022-00279
    Event Type
    Malfunction
    Date Received
    May 19, 2022
    Date of Event
    May 5, 2022
    Report Date
    June 27, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    UDI-DI
    50382903679602
    PMA / PMN Number
    K945952
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 CUSTOMER 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. 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. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARIN (LH) BLOOD COLLECTION TUBES CUSTOMER HAD AN ELEVATED POTASSIUM LEVEL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: PER CUSTOMER, THIS WEEKEND THEY HAD A PATIENT WHO HAD A WHITE COUNT OF 285,000. THE ORIGINAL POTASSIUM WAS RUN OFF OF THE GREEN TOP TUBE AND PRODUCED A RESULT OF 7.7. CUSTOMER IS AWARE THAT AN ELEVATED WHITE COUNT CAN PRODUCE FALSELY ELEVATED POTASSIUM RESULTS IN A LITHIUM HEPARIN TUBE, SO THE RESULT WAS LATER RUN ON A RED TOP TUBE AND PRODUCED A RESULT OF 4.4. UNFORTUNATELY, THIS PATIENT WAS TREATED OFF OF THE 7.7 POTASSIUM RESULT AS THE REALIZATION OF THE NEED TO RUN ON THE RED TOP TUBE WAS NOT MADE UNTIL MUCH LATER. THE MANUFACTURER OF OUR INSTRUMENTATION WAS AWARE OF THE EFFECT BUT THERE IS NO INDICATION IN THEIR METHODOLOGY SOP. STEPS TAKEN WITH CUSTOMER/TROUBLESHOOTING: DOCUMENTED THE COMPLAINT, REACHED OUT TO (B)(6), PENDING INFORMATION FROM MARKETING. DID THE SPECIMEN(S) NEED TO BE RECOLLECTED? N. DID EXPOSURE TO BLOOD/ BF OCCUR? N. IF EXPOSURE OCCURRED WAS THERE ANY POST EXPOSURE TESTING OR MEDICAL INTERVENTION? N. NEXT STEPS (IF NECESSARY): PENDING CONSULTATION WITH PAS MARKETING. RESOLUTION ACHIEVED (Y/N)? N. QUANTITY RECEIVED AND QUANTITY AFFECTED: 1. SHIPMENT METHOD (DIRECTLY OR VIA DISTRIBUTOR): N/A. IF IT IS A DISTRIBUTOR OR DIRECTLY FROM BD ¿ WHO IS IT? N/A. PHOTOS OR RETURNS REQUESTED? N. FOLLOW UP REQUIRED Y/N? Y. REVIEWED SMAX CASE HISTORY: NO BD CAT # AVAILABLE TO CHECK THE HISTORY OF THIS ISSUE. (B)(6) : (B)(6) 2022 21:57:10 (GMT). (B)(4) LITHIUM HEPARIN TUBES RESULTS ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) BLOOD COLLECTION TUBES CUSTOMER HAD AN ELEVATED POTASSIUM LEVEL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: PER CUSTOMER, THIS WEEKEND THEY HAD A PATIENT WHO HAD A WHITE COUNT OF 285,000. THE ORIGINAL POTASSIUM WAS RUN OFF OF THE GREEN TOP TUBE AND PRODUCED A RESULT OF 7.7. CUSTOMER IS AWARE THAT AN ELEVATED WHITE COUNT CAN PRODUCE FALSELY ELEVATED POTASSIUM RESULTS IN A LITHIUM HEPARIN TUBE, SO THE RESULT WAS LATER RUN ON A RED TOP TUBE AND PRODUCED A RESULT OF 4.4. UNFORTUNATELY, THIS PATIENT WAS TREATED OFF OF THE 7.7 POTASSIUM RESULT AS THE REALIZATION OF THE NEED TO RUN ON THE RED TOP TUBE WAS NOT MADE UNTIL MUCH LATER. THE MANUFACTURER OF OUR INSTRUMENTATION WAS AWARE OF THE EFFECT BUT THERE IS NO INDICATION IN THEIR METHODOLOGY SOP. STEPS TAKEN WITH CUSTOMER/TROUBLESHOOTING: DOCUMENTED THE COMPLAINT, REACHED OUT TO (B)(6), PENDING INFORMATION FROM MARKETING DID THE SPECIMEN(S) NEED TO BE RECOLLECTED?: N. DID EXPOSURE TO BLOOD/ BF OCCUR?: N. IF EXPOSURE OCCURRED WAS THERE ANY POST EXPOSURE TESTING OR MEDICAL INTERVENTION?/: N. NEXT STEPS (IF NECESSARY): PENDING CONSULTATION WITH PAS MARKETING RESOLUTION ACHIEVED (Y/N)? : N. QUANTITY RECEIVED AND QUANTITY AFFECTED: 1. SHIPMENT METHOD (DIRECTLY OR VIA DISTRIBUTOR): N/A. IF IT IS A DISTRIBUTOR OR DIRECTLY FROM BD ¿ WHO IS IT?: N/A. PHOTOS OR RETURNS REQUESTED? : N. FOLLOW UP REQUIRED Y/N?: Y. REVIEWED SMAX CASE HISTORY: NO BD CAT # AVAILABLE TO CHECK THE HISTORY OF THIS ISSUE. (B)(6) : 2022-05-05 21:57:10 (GMT). SM 36XXXX LITHIUM HEPARIN TUBES RESULTS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1893153 BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) 367960 1350376 50382903679602

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown