BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 23393454 · Received October 27, 2025

    Report

    Report Number
    1125230-2025-00049
    Event Type
    Malfunction
    Date Received
    October 27, 2025
    Report Date
    October 27, 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 WERE RECEIVED FROM THE CUSTOMER AND ARE BEING 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 REPORTED TUBES UNDERFILLED. UPDATE 21OCT2025: CUSTOMER ADVISED THEIR COLLECTION PROCESS IS AS FOLLOWS - COLLECTION PROCESS: IV WITH ANGIOCATH WITH EXTENDER THEN PULLING INTO A 10CC SYRINGE. 22 TO 18 GAUGE BLUNT NEEDLE TO START IV LINE. PRIME LINE ATTACHED 10 CC SYRINGE AND PULL. PRESSURE FILLS. THE REST NEEDS TO BE PUSHED WITH THIS LOT. PAST LOTS, NO ISSUES, USUALLY WITH MALE ADAPTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2428036 VACUETTE® TUBE 3 ML 9NC COAGULATION SODIUM CITRATE 3.2% 13X75 EVACUATED BLOOD COLLECTION TUBE GIM GREINER BIO-ONE NA INC. 454351 B2504346

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown