BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 15799355 · Received November 15, 2022

    Report

    Report Number
    1917413-2022-00719
    Event Type
    Malfunction
    Date Received
    November 15, 2022
    Date of Event
    September 16, 2022
    Report Date
    March 21, 2023
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    UDI-DI
    00382903679621
    PMA / PMN Number
    K945952
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1350381; MEDICAL DEVICE EXPIRATION DATE: 2022-12-31; DEVICE MANUFACTURE DATE: 2021-12-16. MEDICAL DEVICE LOT #: 2080690; MEDICAL DEVICE EXPIRATION DATE: 2023-03-31; DEVICE MANUFACTURE DATE: 2022-03-21. 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

    H6: INVESTIGATION SUMMARY: MATERIAL #: 367962. LOT/BATCH #: 1350381, UNKNOWN. BD RECEIVED 2 SAMPLES FOR INVESTIGATION. 100 RETENTIONS WERE INSPECTED WITH NO ISSUES BEING IDENTIFIED. CLINICAL TESTING COULD NOT BE CONDUCTED AS THE SAMPLES HAD ALREADY EXPIRED AT THE TIME OF REVIEW. 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. A COMPLAINT HISTORY WAS CONDUCTED AND ONLY THIS COMPLAINT HAS BEEN RECEIVED ON THIS BATCH NUMBER AND THE REPORTED DEFECT. 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. 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. CUSTOMER RECOMMENDATION: TO ASSURE HIGH QUALITY SPECIMENS, SEVERAL FACTORS ARE KEY. INCLUDED, BUT NOT LIMITED TO THIS ARE: PROPER PHLEBOTOMY TECHNIQUE TO MINIMIZE HEMOLYSIS AND PLATELET ACTIVATION, PROPER TUBE FILL VOLUME TO ASSURE THE PROPER BLOOD-TO-ADDITIVE RATION, GENTLE AND THOROUGH MIXING, PROPER CENTRIFUGATION CONDITIONS-G FORCE AND TIME, AND STORAGE CONDITIONS. A DISCARD TUBE MUST BE USED WHEN USING A WINGED BLOOD COLLECTION SET FOR VENIPUNCTURE, IN ORDER TO FILL THE BLOOD COLLECTION SET TUBING¿S ¿DEAD SPACE¿ WITH BLOOD. IT IS NOT NECESSARY TO FILL THE DISCARD TUBE COMPLETELY. THIS STEP WILL ENSURE MAINTENANCE OF THE PROPER BLOOD-ADDITIVE-RATIO OF THE SPECIMEN. THE DISCARD TUBE SHOULD BE A NON-ADDITIVE OR COAGULATION TUBE. ADHERENCE TO THE RECOMMENDED SPECIMEN HANDLING AND PROCESSING STEPS WILL FACILITATE ACCEPTABLE SPECIMEN QUALITY AND OVERALL PERFORMANCE FOR RELIABLE ANALYTICAL OUTCOMES. EVALUATION OF LABORATORY INSTRUMENTATION REGARDING REPRODUCIBILITY/REPEATABILITY MAY BE OF VALUE. INSTRUMENT MANUFACTURER¿S SPECIMEN TYPE RECOMMENDATIONS AND VALIDATION PROCEDURES REVIEWED. A REVIEW OF SPECIMEN HANDLING PARAMETERS WOULD BE OF VALUE FOR THIS TUBE TYPE. ATTACHED ARE OUR PST¿ TECHTALK AND A PUBLICATION ADDRESSING HEPARIN PLASMA TESTING IN CLINICAL CHEMISTRY.

    Additional Manufacturer Narrative · 0

    B.5. EVENT DESCRIPTION: IT WAS REPORTED WHEN USING THE BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARIN (LH) BLOOD COLLECTION TUBES, THE DEVICE EXPERIENCED ERRONEOUS RESULTS. PATIENT A. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: CUSTOMER STATED THAT TODAY, 09/16, SHE PULLED ALL THREE TUBES FOR THIS PATIENT DRAW ON (B)(6) 2022 SHE SAID THAT THEY WERE RUN ON ALL FOUR COBAS INSTRUMENTS THE RESULTS FROM EACH TUBE MATCHED THE RESULTS GENERATED ON THE I1, I2, I3 AND I4 COBAS LINES PREVIOUSLY FOR REFERENCE: PATIENT A) MALE- SI 6.0-ELEVATED POTASSIUM RESULTS PATIENT A) MALE-SI 5.9-ELEVATED POTASSIUM RESULTS PATIENT A) MALE NORMAL LEVELS 5.2 B.6. RELEVANT TESTS/LABORATORY DATA: PATIENT A) 6.0-ELEVATED POTASSIUM RESULTS PATIENT A) MALE-SI 5.9-ELEVATED POTASSIUM RESULTS PATIENT A) MALE NORMAL LEVELS 5.2 D.4. DEVICE LOT #: ORIGINALLY LOT NUMBER 2080690 WAS REPORTED. THIS LOT WAS NOT INVOLVED. D.4. MEDICAL DEVICE LOT #: 2080690 D.4. MEDICAL DEVICE EXPIRATION DATE: 2023-03-31 H.4. DEVICE MANUFACTURE DATE: 2022-03-21

    Additional Manufacturer Narrative · 0

    THIS CORRECTION REPORT IS BEING SENT TO CORRECT THE PREVIOUSLY SUBMITTED REPORT. DATE RECEIVED BY MANUFACTURER IS 09-NOV-2022.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARIN (LH) BLOOD COLLECTION TUBES, THE DEVICE EXPERIENCED ERRONEOUS RESULTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: IT WAS REPORTED BY THE CUSTOMER THAT SAMPLES IN TUBES ARE GIVING ERRONEOUS RESULTS. END USER SUMMIT MEDICAL GROUP LAB IS ALLEGING ERRONEOUSLY HIGH POTASSIUM RESULTS WITH THE BD VACUTAINER LITHIUM HEPARIN TUBES CUSTOMER IS ALLEGING ERRONEOUS POTASSIUM RESULTS WITH THE LITHIUM HEPARIN TUBE.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) BLOOD COLLECTION TUBES, THE DEVICE EXPERIENCED ERRONEOUS RESULTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: IT WAS REPORTED BY THE CUSTOMER THAT SAMPLES IN TUBES ARE GIVING ERRONEOUS RESULTS. END USER SUMMIT MEDICAL GROUP LAB IS ALLEGING ERRONEOUSLY HIGH POTASSIUM RESULTS WITH THE THE BD VACUATINER LITHIUM HEPARIN TUBES CUSTOMER IS ALLEGING ERRONEOUS POTASSIUM RESULTS WITH THE LITHIUM HEPARIN TUBE.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) BLOOD COLLECTION TUBES, THE DEVICE EXPERIENCED ERRONEOUS RESULTS. PATIENT A. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: CUSTOMER STATED THAT TODAY, 09/16, SHE PULLED ALL THREE TUBES FOR THIS PATIENT DRAW ON (B)(6) /2022 SHE SAID THAT THEY WERE RUN ON ALL FOUR COBAS INSTRUMENTS THE RESULTS FROM EACH TUBE MATCHED THE RESULTS GENERATED ON THE I1, I2, I3 AND I4 COBAS LINES PREVIOUSLY FOR REFERENCE: PATIENT A) MALE- SI 6.0-ELEVATED POTASSIUM RESULTS PATIENT A) MALE-SI 5.9-ELEVATED POTASSIUM RESULTS PATIENT A) MALE NORMAL LEVELS 5.2

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) BLOOD COLLECTION TUBES, THE DEVICE EXPERIENCED ERRONEOUS RESULTS. PATIENT A. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: CUSTOMER STATED THAT TODAY, 09/16, SHE PULLED ALL THREE TUBES FOR THIS PATIENT DRAW ON 09/15/2022. SHE SAID THAT THEY WERE RUN ON ALL FOUR COBAS INSTRUMENTS. THE RESULTS FROM EACH TUBE MATCHED THE RESULTS GENERATED ON THE I1, I2, I3 AND I4 COBAS LINES PREVIOUSLY FOR REFERENCE: PATIENT A). MALE- SI 6.0-ELEVATED POTASSIUM RESULTS. PATIENT A) MALE-SI 5.9-ELEVATED POTASSIUM RESULTS. PATIENT A) MALE NORMAL LEVELS 5.2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1021112 BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) SEE H.10. 00382903679621

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown