BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VACUETTE® TUBE 2 ML 9NC COAGULATION SODIUM CITRATE 3.2% 13X75

    MDR report key: 23623777 · Received November 21, 2025

    Report

    Report Number
    1125230-2025-00053
    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
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). RECEIVED 1RK 454322/B250733B FOR EVALUATION. RECEIVED CUSTOMER PICTURE. WE HAVE NO FURTHER INVENTORY OF THE MATERIAL/BATCH. WE HAVE NO FURTHER COMPLAINTS ON THE MATERIAL/BATCH. A CHECK OF QUALITY, PRODUCTION, AND MAINTENANCE RECORDS REVEALED NO DEVIATIONS IN RELATION TO THE REPORTED ERROR. 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. THE COMPLAINT COULD NOT BE DUPLICATED. 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 TUBES ARE UNDERFILLING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2075782 VACUETTE® TUBE 2 ML 9NC COAGULATION SODIUM CITRATE 3.2% 13X75 EVACUATED BLOOD COLLECTION TUBE GIM GREINER BIO-ONE NA INC. 454322 B250733B

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown