BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 21945869 · Received May 1, 2025

    Report

    Report Number
    1125230-2025-00014
    Event Type
    Malfunction
    Date Received
    May 1, 2025
    Report Date
    April 28, 2025
    Manufacturer
    GREINER BIO-ONE NORTH AMERICA, 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 RECEIVED AND 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 10PC 454323/B240733D FOR EVALUATION. A CHECK OF QUALITY, PRODUCTION, AND MAINTENANCE RECORDS REVEALED NO DEVIATIONS IN RELATION TO THE REPORTED ERROR. NO VISUAL DEVIATIONS WERE NOTED FOR ANY OF THE RETURNED SAMPLES. THE CUSTOMER RETURNED SAMPLES WERE SLIGHTLY HIGHER THAN THE TOLERANCE RANGE. HOWEVER, THE CITRATE TO BLOOD RATIO IS THE IMPORTANT FACTOR IN COAGULATION TESTING. MIXING RATIO BETWEEN CITRATE AND BLOOD IS STILL IN RANGE. THE COMPLAINT CANNOT BE CONFIRMED. CORRECTED DATA: H6: TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSION; H11: MANUFACTURER NARRATIVE.

    Description of Event or Problem · 0

    CUSTOMER STATES TUBE UNDERFILLED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194325 VACUETTE® TUBE 2 ML 9NC COAGULATION SODIUM CITRATE 3.2% 13X75 EVACUATED BLOOD COLLECTION TUBES GIM GREINER BIO-ONE NORTH AMERICA, INC 454323 B240733D

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown