BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VACUETTE® TUBE 3 ML 9NC COAGULATION SODIUM CITRATE 3.2% 13X75, UNKNOWN

    MDR report key: 23863420 · Received December 22, 2025

    Report

    Report Number
    1125230-2025-00056
    Event Type
    Malfunction
    Date Received
    December 22, 2025
    Report Date
    December 22, 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): 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.

    Additional Manufacturer Narrative · 0

    (B)(4): NO SAMPLES WERE RECEIVED FOR EVALUATION. THE COMPLAINT CANNOT BE DETERMINED. CORRECTED DATA: H6: INVESTIGATION FINDINGS, INVESTIGATION CONCLUSION; H11: MANUFACTURER NARRATIVE.

    Description of Event or Problem · 0

    CUSTOMER ADVISED THEY ARE HAVING ISSUES WITH BLUE TOPS UNDERFILLING TO THE INDICATOR. CUSTOMER IDENTIFIED LOT B250833T AND OCCURRENCES ACROSS OTHER UNKNOWN LOTS. CUSTOMER ADVISED MANY OF THE TUBES THAT WERE PROBLEMATIC HAVE GONE PAST THEIR STORAGE LIMITS AND WERE DISCARDED, SO THEY ARE IMPOSSIBLE TO OBTAIN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1662744 VACUETTE® TUBE 3 ML 9NC COAGULATION SODIUM CITRATE 3.2% 13X75, UNKNOWN EVACUATED BLOOD COLLECTION TUBE GIM GREINER BIO-ONE NA INC. 454351, UNKNOWN B250833T, UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown