BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® LH (LITHIUM HEPARIN) 68 I.U. PLUS BLOOD COLLECTION TUBES

    MDR report key: 17421808 · Received July 30, 2023

    Report

    Report Number
    9617032-2023-00985
    Event Type
    Malfunction
    Date Received
    July 30, 2023
    Date of Event
    March 13, 2023
    Report Date
    October 10, 2023
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    PMA / PMN Number
    K901449
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WERE THREE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH ADDITIONAL LOT NUMBER IS AS FOLLOWS: D4. MEDICAL DEVICE LOT#: 3002654. D4. MEDICAL DEVICE EXPIRATION DATE: 30-04-2024. H4. DEVICE MANUFACTURE DATE: 02-01-2023. D4. MEDICAL DEVICE LOT#: 3031235. D4. MEDICAL DEVICE EXPIRATION DATE: 31-05-2024. H4. DEVICE MANUFACTURE DATE: 31-01-2023. H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY: BD RECEIVED 1 CONTAMINATED SAMPLE FOR INVESTIGATION. THE CUSTOMER SAMPLE WAS NOT EVALUATED AND DISCARDED AS ONLY UNUSED TUBES ARE NEEDED FOR INVESTIGATION. ADDITIONALLY 100 RETENTION SAMPLES OF THE INCIDENT LOT SELECTED AND EVALUATED FROM BD INVENTORY NO ISSUES RELATING TO FOREIGN MATTER WERE OBSERVED. ONE CONTAMINATED SAMPLE WAS RECEIVED AT THE PLANT AND DISPOSED OF IMMEDIATELY THEREFORE, CLINICAL TESTING WAS PERFORMED WITH RETENTION SAMPLES. THERE WERE NO DIFFICULTIES ENCOUNTERED DURING BLOOD COLLECTION AND ALL TUBES EXHIBITED PROPER FILL. BD WAS UNABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE (ERRONEOUS RESULTS-TROPONIN T) BECAUSE THE DEFECT WAS NOT EVIDENT IN THE TESTING OF THE COMPLAINT LOT SAMPLES. DUE TO SUPPLY ISSUES LOT 3031235 WAS UNABLE TO BE TESTED; HOWEVER LOTS 3002654, AND 3030787 WERE TESTED. REPLICATES OF BOTH RETAIN AND CONTROL SAMPLES WERE ACCEPTABLE IN TERMS OF BOTH PRECISION AND ACCURACY. HOWEVER, BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE, FOREIGN MATTER-PARTICLES, BECAUSE THE DEFECT WAS EVIDENT IN THE CLINICAL TESTING OF THE COMPLAINT LOT SAMPLES BD WILL CONTINUE TO MONITOR FOR ADDITIONAL COMPLAINTS AND EMERGING TRENDS. 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 NOT CONFIRMED FOR ERRONEOUS RESULTS-TROPONIN T BUT CONFIRMED FOR FOREIGN MATTER-PARTICLES. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. FACTORS THAT MAY CONTRIBUTE TO ERRONEOUS RESULTS-TROPONIN T AND FOREIGN MATTER-PARTICLES 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 WITH ANALYTE TESTING AND WE WERE UNABLE TO DETERMINE ANY EXTERNAL CONTRIBUTOR TO THIS REPORTED ISSUE. 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. WHEN USING A WINGED BLOOD COLLECTION SET FOR VENIPUNCTURE, A DISCARD TUBE MUST BE USED TO FILL THE BLOOD COLLECTION SET TUBING¿S ¿DEAD SPACE¿ WITH BLOOD. THE DISCARD DOES NOT NEED TO BE FILLED COMPLETELY. 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. 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 WHILE USING BD VACUTAINER® LH (LITHIUM HEPARIN) 68 I.U. PLUS BLOOD COLLECTION TUBES, THERE ARE ERRONEOUS RESULTS AND PARTICLES FLOATING ON THE SURFACE OF THE PLASMA OF AN UNSPECIFIED NUMBER OF TUBES ACROSS THREE LOT NUMBERS. NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "SHORT DESCRIPTION : DISCORDANT TROPONIN RESULTS ON ROCHE COBAS 8000 WHEN DID THE INCIDENT OCCUR? DURING USE DISCORDANT TROPONIN RESULTS GOING FROM 100-200 TO 15-20 PARTICLES FLOATING ON THE SURFACE OF THE PLASMA."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD VACUTAINER® LH (LITHIUM HEPARIN) 68 I.U. PLUS BLOOD COLLECTION TUBES, THERE ARE ERRONEOUS RESULTS AND PARTICLES FLOATING ON THE SURFACE OF THE PLASMA OF AN UNSPECIFIED NUMBER OF TUBES ACROSS THREE LOT NUMBERS. NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "SHORT DESCRIPTION : DISCORDANT TROPONIN RESULTS ON ROCHE COBAS 8000 WHEN DID THE INCIDENT OCCUR? DURING USE DISCORDANT TROPONIN RESULTS GOING FROM 100-200 TO 15-20 PARTICLES FLOATING ON THE SURFACE OF THE PLASMA."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654352 BD VACUTAINER® LH (LITHIUM HEPARIN) 68 I.U. PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 3030787

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown