BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VACUETTE® TUBE 3 ML 9NC COAGULATION SODIUM CITRATE 3.2% 13X75 HIGH ALTITUDE

    MDR report key: 23328299 · Received October 17, 2025

    Report

    Report Number
    1125230-2025-00047
    Event Type
    Malfunction
    Date Received
    October 17, 2025
    Report Date
    October 17, 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). CUSTOMER SAMPLES HAVE BEEN REQUESTED BUT NOT YET RECEIVED AT THE TIME OF THIS REPORT. IF AND WHEN SAMPLES ARRIVE, SAMPLES 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

    COMPLAINT: (B)(4). RECEIVED 1 RACK 454351/B2504346 FOR EVALUATION. 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.

    Description of Event or Problem · 0

    CUSTOMER STATES THIS LOT IS NOT FILLING TO THE ACCEPTABLE WINDOW FOR COAG TESTING. THIS IS OCCURRING IN THE EMERGENCY DEPARTMENT AT GRANDVIEW. THEY SAID THE VACUUM IS STOPPING AT 2.5ML FOR THE 3ML TUBE. MULTIPLE DIFFERENT TUBES WERE USED FROM DIFFERENT TRAYS AND ALL EXHIBITED THE SAME ISSUE WHEN TRIALING THESE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    14093 VACUETTE® TUBE 3 ML 9NC COAGULATION SODIUM CITRATE 3.2% 13X75 HIGH ALTITUDE EVACUATED BLOOD COLLECTION TUBE GIM GREINER BIO-ONE NA INC. 454351 B2504346

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown