BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VACUETTE® TUBE 3 ML 9NC COAGULATION SODIUM CITRATE 3.2%, VACUETTE® TUBE 2 ML 9NC

    MDR report key: 23623772 · Received November 21, 2025

    Report

    Report Number
    1125230-2025-00054
    Event Type
    Malfunction
    Date Received
    November 21, 2025
    Report Date
    November 20, 2025
    Manufacturer
    GREINER BIO-ONE NA INC.
    Product Code
    GIM
    PMA / PMN Number
    K971221
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT (B)(4): NO SAMPLES OF 454351/B2504346 NOR 454351/B25053GL WERE RECEIVED FOR EVALUATION. THESE PORTIONS OF THE COMPLAINT CANNOT BE DETERMINED. RECEIVED 1RK 454351/B250833S FOR EVALUATION. RECEIVED CUSTOMER PICTURE. A CHECK OF QUALITY, PRODUCTION, AND MAINTENANCE RECORDS REVEALED NO DEVIATIONS IN RELATION TO THE REPORTED ERRORS. TUBES WERE VERIFIED TO BE CORRECTLY ASSEMBLED WITH NO DEVIATIONS OBSERVED. NO VISUAL DEVIATION IN FILL VOLUME, SPORADIC LOW OR HIGH FILL, COULD BE OBSERVED IN THE TESTED SAMPLES. ALL TUBES TESTED FILLED WITHIN THE +/-10% TOLERANCE RANGE. ADDITIVE CONTENT WAS FOUND TO BE WITHIN SPECIFICATION IN ALL TESTED SAMPLES. THIS PORTION OF THE COMPLAINT COULD NOT BE CONFIRMED. CORRECTED DATA: H6: TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSION; H11: MANUFACTURER NARRATIVE.

    Additional Manufacturer Narrative · 0

    COMPLAINT: (B)(4). SAMPLES HAVE BEEN REQUESTED FROM THE CUSTOMER BUT HAVE NOT YEAR BEEN RECEIVED AT THE TIME OF THIS REPORT. IF AND WHEN CUSTOMER SAMPLES ARE RECEIVED, THEY WILL BE EVALUATED AS PART OF THE COMPLAINT INVESTIGATION. UPON COMPLETION OF THE COMPLAINT INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    CUSTOMER ADVISED THEY EXPERIENCED UNDERFILLED AND OVERFILLED SPECIMENS WITH B2504346 AND B250833S. CUSTOMER ADVISED THEY EXPERIENCED ONE CLOTTED SPECIMEN WITH B250833S, AND ONE CLOTTED SPECIMEN WITH B25053GL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2075777 VACUETTE® TUBE 3 ML 9NC COAGULATION SODIUM CITRATE 3.2%, VACUETTE® TUBE 2 ML 9NC EVACUATED BLOOD COLLECTION TUBE GIM GREINER BIO-ONE NA INC. 454351, 454323 B2504346, B250833S, B25053GL

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown