BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VACUETTE® TUBE 3.5 ML 9NC COAGULATION SODIUM CITRATE 3.2% 13X75

    MDR report key: 23878315 · Received December 23, 2025

    Report

    Report Number
    1125230-2025-00027
    Event Type
    Malfunction
    Date Received
    December 23, 2025
    Report Date
    December 23, 2025
    Manufacturer
    GREINER BIO-ONE NA INC.
    Product Code
    GIM
    PMA / PMN Number
    K971221
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT (B)(4): NO SAMPLES WERE RECEIVED FOR EVALUATION. A CHECK OF QUALITY, PRODUCTION, AND MAINTENANCE RECORDS REVEALED NO DEVIATIONS IN RELATION TO THE REPORTED ERROR. THE COMPLAINT IS CLOSED AS CANNOT BE DETERMINED. THE MDR WAS ORIGINALLY SUBMITTED IN (B)(6) 2025 BUT FAILED TRANSMISSION DUE TO AN INTERNAL CLERICAL ERROR INVOLVING DUPLICATION OF THE ASSIGNED MANUFACTURER REPORT NUMBER, WHICH LED TO THE FAILURE OF THE INITIAL SUBMISSION. THE ERROR WAS NOT DETECTED AT THE TIME AND WAS SUBSEQUENTLY IDENTIFIED DURING A COMPREHENSIVE REVIEW OF ALL MDRS SUBMITTED IN 2025. MDR IS BEING RESUBMITTED IMMEDIATELY UPON DISCOVERY, AND A ROOT CAUSE INVESTIGATION HAS BEEN INITIATED TO DETERMINE AREAS FOR CORRECTION AND ENHANCEMENT WITHIN OUR INTERNAL MDR PREPARATION AND SUBMISSION PROCESS.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED AN ISSUE WITH THE TUBES; THEY ARE NOT CONSISTENTLY FILLING ALL OF THE WAY. IT APPEARS THERE IS AN ISSUE WITH THE VACUUM OCCURRING SINCE (B)(6). TUBES FILL TO EITHER THE VERY BOTTOM OF THE ARROW (ACCEPTABLE) OR TO JUST HALFWAY FILLED. WINGED NEEDLE USED WITH A FULL DISCARD TUBE COLLECTED PRIOR. TUBES HELD IN HOLDER BY PRESSING WITH THUMB FOR COMPLETE VACUUM FILL PER IFU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2507469 VACUETTE® TUBE 3.5 ML 9NC COAGULATION SODIUM CITRATE 3.2% 13X75 EVACUATED BLOOD COLLECTION TUBE GIM GREINER BIO-ONE NA INC. 454332 B240833S

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown