BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® 9NC 0.109M BUFFERED TRISODIUM CITRATE PLUS BLOOD COLLECTION TUBE

    MDR report key: 8693622 · Received June 12, 2019

    Report

    Report Number
    9617032-2019-00684
    Event Type
    Malfunction
    Date Received
    June 12, 2019
    Date of Event
    May 27, 2019
    Report Date
    August 19, 2019
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    UDI-DI
    50382903630481
    PMA / PMN Number
    K013971
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: INVESTIGATION SUMMARY: A SINGLE CUSTOMER REPORTED DRAW VOLUME (OVERFILL) ISSUES WHICH THEY INDICATED RESULTED IN ERRONEOUS RESULTS WHILE USING THE BD VACUTAINER® PLUS SODIUM CITRATE BLOOD COLLECTION TUBE (REFERENCE CATALOG NUMBER 363048, LOT NUMBER 9031922). TUBE DRAW VOLUME (OVERFILL) ISSUES CAN BE ATTRIBUTED TO PRODUCT PERFORMANCE OR PRE-ANALYTICAL (SAMPLE COLLECTION TECHNIQUES) FACTORS. FROM A PRODUCT PERFORMANCE PERSPECTIVE, BD PAS DOES NOT BELIEVE THIS TO BE A PRODUCT PERFORMANCE ISSUE AS THE INTERNAL TESTING (DRAW VOLUME) ON CUSTOMER SAMPLES FROM THE INCIDENT LOT DEMONSTRATED THAT ALL TUBES MET THE ESTABLISHED SPECIFICATION LIMITS AND THERE WERE NO PRODUCT-RELATED ISSUES IDENTIFIED TO TUBE OVERFILLING. TUBE OVERFILLING CAN RESULT IN POTENTIAL ERRONEOUS RESULTS DUE TO AN INCORRECT BLOOD-TO-ADDITIVE RATIO. ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET; THERE WERE NO RELATED QUALITY NON-CONFORMANCE'S DURING MANUFACTURING OF THE PRODUCT. ALSO, BD PAS PERFORMED A DEVICE HISTORY REVIEW (DHR) WHICH DID NOT IDENTIFY ANY ISSUES THAT COULD HAVE CONTRIBUTED TO THE CUSTOMER¿S REPORTED FAILURE MODE. FROM A PRE-ANALYTICAL PERSPECTIVE, THE PHLEBOTOMIST ULTIMATELY CONTROLS THE TOTAL AMOUNT OF SPECIMEN COLLECTED FROM A PATIENT AND MUST FOLLOW BEST PHLEBOTOMY AND BLOOD COLLECTION PRACTICES IN ACCORDANCE WITH THE PRODUCT¿S INSTRUCTIONS FOR USE (IFU). WHILE A DEFINITIVE ROOT CAUSE COULD NOT BE ESTABLISHED, BD PAS BELIEVES THE DRAW VOLUME (OVERFILL) ISSUE IS MOST LIKELY RELATED TO A PRE-ANALYTICAL ERROR DURING SPECIMEN COLLECTION. INVESTIGATION CONCLUSION: BASED ON EVALUATION OF THE CUSTOMER SAMPLES, THE CUSTOMER¿S INDICATED FAILURE MODE 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 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 THERE WERE ERRONEOUS RESULTS WITH A BD VACUTAINER® 9NC 0.109M BUFFERED TRISODIUM CITRATE PLUS BLOOD COLLECTION TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: WE HAD 2 CLAIMS FOR ABERRANT HAEMOSTASIS RESULTS: TP (PROTHROMBIN TIME) SIGNIFICANTLY REDUCED BY ABOUT 20% AND TCK (APTT) PROLONGED WITHOUT ANTICOAGULANT THERAPY. AFTER RECHECKING ON NEW SAMPLE, THE RESULTS ARE NORMAL. WE HAVE RE-ANALYZED TP AND TCK ON THE FIRST TUBES AND THEY TURN OUT TO BE NORMAL. BY TAKING THE RESULTS BACK WE FOUND 4 ABERRANT RESULTS. ON FRIDAY EVENING, THE AUTOMATON REPEATEDLY DISPLAYED THE QIP ALARM FOR INSUFFICIENT QUANTITY WITHOUT GIVING A RESULT, REQUIRING A RELAUNCH ON SEVERAL BALANCE SHEETS. FURTHER INFORMATION = TUBES ARE FILLED TOO HIGH AND IT SEEMS ABOVE THE TOLERANCE OF +10 %. WE WILL GET SAMPLES BACK. THE PROBLEM OCCURS ON OUR TWO AUTOMATA. THE SET OF TUBES IS 9031922 (REF 363048) I SUSPECT A PIPETTING PROBLEM RELATED TO THE PRESENCE OF PLASMA UNDER THE PLUG DETECTED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. (B)(6). DEVICE EVALUATED BY MFR: 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 THERE WERE ERRONEOUS RESULTS WITH A BD VACUTAINER® 9NC 0.109M BUFFERED TRISODIUM CITRATE PLUS BLOOD COLLECTION TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAD 2 CLAIMS FOR ABERRANT HAEMOSTASIS RESULTS: TP (PROTHROMBINE TIME) SIGNIFICANTLY REDUCED BY ABOUT 20% AND TCK (APTT) PROLONGED WITHOUT ANTICOAGULANT THERAPY. AFTER RECHECKING ON NEW SAMPLE, THE RESULTS ARE NORMAL. WE HAVE RE-ANALYZED TP AND TCK ON THE FIRST TUBES AND THEY TURN OUT TO BE NORMAL. BY TAKING THE RESULTS BACK WE FOUND 4 ABERRANT RESULTS. ON FRIDAY EVENING, THE AUTOMATON REPEATEDLY DISPLAYED THE QIP ALARM FOR INSUFFICIENT QUANTITY WITHOUT GIVING A RESULT, REQUIRING A RELAUNCH ON SEVERAL BALANCE SHEETS. FURTHER INFORMATION = TUBES ARE FILLED TOO HIGH AND IT SEEMS ABOVE THE TOLERANCE OF +10 %. WE WILL GET SAMPLES BACK. THE PROBLEM OCCURS ON OUR TWO AUTOMATA. THE SET OF TUBES IS 9031922 (REF 363048) I SUSPECT A PIPETTING PROBLEM RELATED TO THE PRESENCE OF PLASMA UNDER THE PLUG DETECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    487128 BD VACUTAINER® 9NC 0.109M BUFFERED TRISODIUM CITRATE PLUS BLOOD COLLECTION TUBE BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 9031922 50382903630481

    Patients

    Seq Age Sex Outcome Treatment
    1 Other