BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® LH PST¿ II PLUS BLOOD COLLECTION TUBES

    MDR report key: 8504668 · Received April 11, 2019

    Report

    Report Number
    9617032-2019-00426
    Event Type
    Malfunction
    Date Received
    April 11, 2019
    Date of Event
    March 10, 2019
    Report Date
    August 2, 2019
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR EVALUATION; THEREFORE, THE INVESTIGATION WAS LIMITED. RETENTION SAMPLES OF THE INCIDENT LOT WERE SELECTED FROM BD INVENTORY FOR EVALUATION AND TESTING AND UPON COMPLETION, NO ISSUES RELATING TO ERRONEOUS RESULTS WERE OBSERVED AS REPLICATES OF RETAIN SAMPLES TESTED WERE ACCEPTABLE IN TERMS OF BOTH PRECISION AND ACCURACY. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR THE INCIDENT LOT AND, BASED ON THIS REVIEW, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET; THERE WERE NO RELATED QUALITY NON-CONFORMANCE'S DURING MANUFACTURING OF THE PRODUCT. INVESTIGATION CONCLUSION: BASED ON EVALUATION OF THE RETAIN SAMPLES, THE CUSTOMER¿S INDICATED FAILURE MODE FOR ERRONEOUS RESULTS WITH THE INCIDENT LOT WAS NOT OBSERVED AS ALL SAMPLES MET THE REQUIRED SPECIFICATIONS. ROOT CAUSE DESCRIPTION: BASED ON THE INVESTIGATION, A ROOT CAUSE COULD NOT BE DETERMINED. THE RETAIN PRODUCT WAS FOUND TO BE IN CONFORMANCE AND MEET RELEASE SPECIFICATIONS. RATIONALE: COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. THE BD BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 BD VACUTAINER® LH PST¿ II PLUS BLOOD COLLECTION TUBES FROM LOT # 8177991, AND 2 TUBES FROM LOT # 8242662, HAD FALSELY ELEVATED LITHIUM TROPONIN LEVELS AFTER RETESTING 3-4 HOURS LATER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "TROPONIN LEVELS IN LITHIUM HEPARIN SAMPLE WERE SIGNIFICANTLY RAISED AFTER RE TESTING AFTER 3 OR 4 HOURS LATER. NO FURTHER ACTION WAS TAKEN AND NO PATIENT RECEIVED UNNECESSARY DIAGNOSIS OR TREATMENT."

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 8177991. MEDICAL DEVICE EXPIRATION DATE: 2019-12-31. DEVICE MANUFACTURE DATE: 2018-06-26. MEDICAL DEVICE LOT #: 8242662. MEDICAL DEVICE EXPIRATION DATE: 2020-03-31. DEVICE MANUFACTURE DATE: 2018-08-30. (B)(6). 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 THAT 2 BD VACUTAINER® LH PST¿ II PLUS BLOOD COLLECTION TUBES FROM LOT # 8177991, AND 2 TUBES FROM LOT # 8242662, HAD FALSELY ELEVATED LITHIUM TROPONIN LEVELS AFTER RETESTING 3-4 HOURS LATER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "TROPONIN LEVELS IN LITHIUM HEPARIN SAMPLE WERE SIGNIFICANTLY RAISED AFTER RE TESTING AFTER 3 OR 4 HOURS LATER. NO FURTHER ACTION WAS TAKEN AND NO PATIENT RECEIVED UNNECESSARY DIAGNOSIS OR TREATMENT".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300231 BD VACUTAINER® LH PST¿ II PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) SEE SECTION H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other