BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER 9NC 0.5 ML BUFFERED TRISODIUM CITRATE BLOOD COLLECTION TUBE

    MDR report key: 12339871 · Received August 18, 2021

    Report

    Report Number
    9617032-2021-00905
    Event Type
    Malfunction
    Date Received
    August 18, 2021
    Date of Event
    July 29, 2021
    Report Date
    August 19, 2021
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    PMA / PMN Number
    K013971
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    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. THIS COMPLAINT IS UNABLE TO BE CONFIRMED. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® 9NC 0.5 ML 0.105M BUFFERED TRISODIUM CITRATE BLOOD COLLECTION TUBE, THE DEVICE EXPERIENCED ERRONEOUS RESULTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: WE WOULD LIKE TO INFORM YOU THAT THE HAEMOSTASIS LABORATORY OF THE EFS IN BESANÇON HAS BEEN EXPERIENCING ANOMALIES IN THE RESULTS OF CERTAIN HAEMOSTASIS TESTS OVER THE LAST FEW MONTHS (PT, TCA, FIBRINOGEN, FII, FV, FVII, FX, FVIII, FIX, FXI, FXII, ANTI-XA ACTIVITY) WHEN TUBES WERE RUN ON SYSMEX CS5100 AND CS2500 ANALYSERS, WHICH ARE NOT CONSISTENT WITH THE HISTORY OF THE PATIENTS OR THE CLINICAL CONTEXT. WHEN AN ANOMALY OR DISCREPANCY IS SUSPECTED, A SECOND RUN IN AN OPEN TUBE IS PERFORMED AND THE RESULTS ARE CONSISTENT. ACCORDING TO THE INFORMATION COLLECTED, THE OCCURRENCE OF THESE DISCREPANCIES OCCURS WHEN THE INSTRUMENT SIGNALS A FILLING ALARM BUT ALSO WITHOUT. PATIENT IMPACT: YES, POSSIBLE IF THE DISCREPANCY IS NOT DETECTED. INCIDENT FREQUENCY: RANDOM 5-6 TUBES / DAY, I.E. 2% (TOTAL NUMBER OF TUBES PROCESSED APPROXIMATELY 300/DAY). NOTE THAT SOMETIMES NO INCIDENT IS OBSERVED FOR SEVERAL DAYS.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® 9NC 0.5 ML 0.105M BUFFERED TRISODIUM CITRATE BLOOD COLLECTION TUBE, THE DEVICE EXPERIENCED ERRONEOUS RESULTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: WE WOULD LIKE TO INFORM YOU THAT THE HAEMOSTASIS LABORATORY OF THE EFS IN BESANÇON HAS BEEN EXPERIENCING ANOMALIES IN THE RESULTS OF CERTAIN HAEMOSTASIS TESTS OVER THE LAST FEW MONTHS (PT, TCA, FIBRINOGEN, FII, FV, FVII, FX, FVIII, FIX, FXI, FXII, ANTI-XA ACTIVITY) WHEN TUBES WERE RUN ON SYSMEX CS5100 AND CS2500 ANALYSERS, WHICH ARE NOT CONSISTENT WITH THE HISTORY OF THE PATIENTS OR THE CLINICAL CONTEXT. WHEN AN ANOMALY OR DISCREPANCY IS SUSPECTED, A SECOND RUN IN AN OPEN TUBE IS PERFORMED AND THE RESULTS ARE CONSISTENT. ACCORDING TO THE INFORMATION COLLECTED, THE OCCURRENCE OF THESE DISCREPANCIES OCCURS WHEN THE INSTRUMENT SIGNALS A FILLING ALARM BUT ALSO WITHOUT. PATIENT IMPACT: YES, POSSIBLE IF THE DISCREPANCY IS NOT DETECTED. INCIDENT FREQUENCY: RANDOM 5-6 TUBES / DAY, I.E. 2% (TOTAL NUMBER OF TUBES PROCESSED APPROXIMATELY 300/DAY). NOTE THAT SOMETIMES NO INCIDENT IS OBSERVED FOR SEVERAL DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1236710 BD VACUTAINER 9NC 0.5 ML BUFFERED TRISODIUM CITRATE BLOOD COLLECTION TUBE BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1