BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 13588656 · Received February 23, 2022

    Report

    Report Number
    9617032-2022-00126
    Event Type
    Malfunction
    Date Received
    February 23, 2022
    Date of Event
    December 22, 2021
    Report Date
    May 16, 2022
    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

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR EVALUATION. ADDITIONALLY, BD WAS UNABLE TO DETERMINE THE SPECIFIC LOT NUMBER ASSOCIATED WITH THIS COMPLAINT; THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED. THE CUSTOMER HAS BEEN COUNSELED BY BD¿S LOCAL CLINICAL CONSULTANTS THAT IT WAS NOT ADVISABLE TO MEASURE THIS PARAMETER ON A TUBE AND COMPARE THE RESULTS TO A BLOOD GAS SYRINGE. ARTERIAL BLOOD GAS ANALYSIS ON A VACUTAINER TUBE IS CONSIDERED AN OFF LABEL PRODUCT USE. THIS COMPLAINT IS UNABLE TO BE CONFIRMED. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THIS COMPLAINT WILL BE REOPENED TO ASSESS THE LEVEL OF INVESTIGATION NEEDED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® LH (LITHIUM HEPARIN) 68 I.U. PLUS BLOOD COLLECTION TUBES, THE DEVICE EXPERIENCED ERRONEOUS RESULTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: TO MY KNOWLEDGE, NO ADVERSE CONSEQUENCES TO THE PATIENT INITIAL ENTRY: A DIFFERENCE IN COHB RESULTS >2% BETWEEN VENOUS AND ARTERIAL SAMPLING WAS NOTED FOR ONE PATIENT. BLOOD GAS ON ARTERIAL WHOLE BLOOD (BECTON DICKINSON BLOOD GAS SYRINGE REF (B)(4) COHB ON VENOUS WHOLE BLOOD (GREEN TUBE HEPARINE 4ML WITHOUT GEL BECTON DICKINSON REF (B)(4) I AM SENDING YOU, BELOW, THE ANSWER FROM SIEMENS; IT SEEMS THAT THE VENOUS TUBE BECTON DICKINSON REF (B)(4) HAS A PROBLEM WITH THE WAY IT IS STERILIZED AND THAT IT CONTAINS CO. IT APPEARS THAT THE VENOUS BECTON DICKINSON REF (B)(4) HAS AN ISSUE WITH THE WAY IT IS STERILIZED AND HAS CO IN IT. IN (B)(6) 2019 BD RELEASED A NOTIFICATION (FALSE ELEVATION OF CARBOXYHEMOGLOBIN) TO CUSTOMERS ADVISING THAT "YOUR FACILITY SHOULD ASSESS THE RISK OF USING THESE TUBES TO MEASURE COHB ON ANY OTHER PLATFORMS". AS A REMINDER, THE DIFFERENCE IN DOSAGE BETWEEN VENOUS AND ARTERIAL COHB IN FILE SF211222420 IS > 2%. SIEMENS' EXPLANATIONS FOR THE DIFFERENCE BETWEEN THE VENOUS AND ARTERIAL COHB ASSAY IN THE SF211222420 FILE (> 2%) ARE NOT CONVINCING BECAUSE: DELAY BETWEEN PATIENT SAMPLES: IT IS A FEW MINUTES SINCE THE ARTERIAL SAMPLE WAS TAKEN JUST AFTER THE VENOUS SAMPLE HEMOLYSIS ON THE VENOUS SAMPLE: THE H-INDEX (HEMOLYSIS) MEASURED ON THE COBAS AUTOMATON OF THE HEP TUBE WITH GEL, USED FOR THE DETERMINATION OF K AND CREATININE, IS ONLY "7" (THRESHOLD 60 TO SEE HEMOLYSIS WITH THE EYE); IN THESE CONDITIONS, IT IS UNLIKELY THAT THE H-INDEX OF THE HEP TUBE WITHOUT GEL USED FOR THE DETERMINATION OF CARBON MONOXIDE IS DIFFERENT. HEP CONCENTRATION OF THE ANALYZED SAMPLES: THE VENOUS HEP TUBE (GREEN TUBE HEPARINE 4ML WITHOUT GEL BECTON DICKINSON REF 368884) WAS COMPLETELY FILLED; THE BLOOD LEVEL OF THE ARTERIAL SYRINGE (BLOOD GAS SYRINGE BECTON DICKINSON REF 364314) WAS ABOUT 1 CM, WHICH IS USUAL HSC CONSULTED WITH SUBJECT MATTER EXPERT (SME) ONE WOULD EXPECT AT MOST 1 UNIT DIFFERENCE BETWEEN ARTERIAL AND VENOUS SAMPLES - EG 5.5 % TO 6.5% - THIS DIFFERENCE IS HIGHER. WHAT IS THE TIME BETWEEN SAMPLE DRAWS (IS THE EVACUATED TUBE VENOUS SAMPLE OLDER) FROM THE PATIENT? NOTE THE K+ IS ALWAYS HIGHER FOR THE VENOUS SAMPLE (ALMOST 1 TE (0.4MM)- PERHAPS THE SAMPLE THERE IS HEMOLYZED MORE SO AND CAN CAUSING THE SPECTRAL ANALYSIS TO CHANGE. A 1% HEMOLYSIS CAN CAUSE THE K+ TO BE OUT OF TE. WHAT IS THE EVACUATED TUBE COMPOSITION - TYPE OF HEPARIN ETC.? .CX FILES FROM THAT DAY OF SAMPLE WOULD BE REQUIRED FOR ADDITIONAL ANALYSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® LH (LITHIUM HEPARIN) 68 I.U. PLUS BLOOD COLLECTION TUBES, THE DEVICE EXPERIENCED ERRONEOUS RESULTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: TO MY KNOWLEDGE, NO ADVERSE CONSEQUENCES TO THE PATIENT. INITIAL ENTRY: A DIFFERENCE IN COHB RESULTS >2% BETWEEN VENOUS AND ARTERIAL SAMPLING WAS NOTED FOR ONE PATIENT. - BLOOD GAS ON ARTERIAL WHOLE BLOOD (BECTON DICKINSON BLOOD GAS SYRINGE REF 364314) - COHB ON VENOUS WHOLE BLOOD (GREEN TUBE HEPARINE 4ML WITHOUT GEL BECTON DICKINSON REF 368884) I AM SENDING YOU, BELOW, THE ANSWER FROM SIEMENS; IT SEEMS THAT THE VENOUS TUBE BECTON DICKINSON REF 368884 HAS A PROBLEM WITH THE WAY IT IS STERILIZED AND THAT IT CONTAINS CO. IT APPEARS THAT THE VENOUS BECTON DICKINSON REF 368884 HAS AN ISSUE WITH THE WAY IT IS STERILIZED AND HAS CO IN IT. IN JUN 2019 BD RELEASED A NOTIFICATION (FALSE ELEVATION OF CARBOXYHEMOGLOBIN) TO CUSTOMERS ADVISING THAT "YOUR FACILITY SHOULD ASSESS THE RISK OF USING THESE TUBES TO MEASURE COHB ON ANY OTHER PLATFORMS". AS A REMINDER, THE DIFFERENCE IN DOSAGE BETWEEN VENOUS AND ARTERIAL COHB IN FILE SF211222420 IS > 2%. SIEMENS' EXPLANATIONS FOR THE DIFFERENCE BETWEEN THE VENOUS AND ARTERIAL COHB ASSAY IN THE SF211222420 FILE (> 2%) ARE NOT CONVINCING BECAUSE: - DELAY BETWEEN PATIENT SAMPLES: IT IS A FEW MINUTES SINCE THE ARTERIAL SAMPLE WAS TAKEN JUST AFTER THE VENOUS SAMPLE - HEMOLYSIS ON THE VENOUS SAMPLE: THE H-INDEX (HEMOLYSIS) MEASURED ON THE COBAS AUTOMATON OF THE HEP TUBE WITH GEL, USED FOR THE DETERMINATION OF K AND CREATININE, IS ONLY "7" (THRESHOLD 60 TO SEE HEMOLYSIS WITH THE EYE); IN THESE CONDITIONS, IT IS UNLIKELY THAT THE H-INDEX OF THE HEP TUBE WITHOUT GEL USED FOR THE DETERMINATION OF CARBON MONOXIDE IS DIFFERENT. - HEP CONCENTRATION OF THE ANALYZED SAMPLES: THE VENOUS HEP TUBE (GREEN TUBE HEPARINE 4ML WITHOUT GEL BECTON DICKINSON REF 368884) WAS COMPLETELY FILLED; THE BLOOD LEVEL OF THE ARTERIAL SYRINGE (BLOOD GAS SYRINGE BECTON DICKINSON REF 364314) WAS ABOUT 1 CM, WHICH IS USUAL. HSC CONSULTED WITH SUBJECT MATTER EXPERT (SME) ONE WOULD EXPECT AT MOST 1 UNIT DIFFERENCE BETWEEN ARTERIAL AND VENOUS SAMPLES - EG 5.5 % TO 6.5% - THIS DIFFERENCE IS HIGHER. WHAT IS THE TIME BETWEEN SAMPLE DRAWS (IS THE EVACUATED TUBE VENOUS SAMPLE OLDER) FROM THE PATIENT? NOTE THE K+ IS ALWAYS HIGHER FOR THE VENOUS SAMPLE (ALMOST 1 TE (0.4MM)- PERHAPS THE SAMPLE THERE IS HEMOLYZED MORE SO AND CAN CAUSING THE SPECTRAL ANALYSIS TO CHANGE. A 1% HEMOLYSIS CAN CAUSE THE K+ TO BE OUT OF TE. WHAT IS THE EVACUATED TUBE COMPOSITION - TYPE OF HEPARIN ETC.? .CX FILES FROM THAT DAY OF SAMPLE WOULD BE REQUIRED FOR ADDITIONAL ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    119904 BD VACUTAINER® LH (LITHIUM HEPARIN) 68 I.U. PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown