BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VACUETTE TUBE 3 ML 9NC COAGULATION SODIUM CITRATE 3,2% 13X75

    MDR report key: 11697043 · Received April 20, 2021

    Report

    Report Number
    1125230-2021-00036
    Event Type
    Malfunction
    Date Received
    April 20, 2021
    Report Date
    April 20, 2021
    Manufacturer
    GREINER BIO-ONE NA INC.
    Product Code
    GIM
    PMA / PMN Number
    K971221
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT CO21-2100-197 RECEIVED 1RK 454334/B20113CT FOR EVALUATION. A CHECK OF QUALITY, PRODUCTION, AND MAINTENANCE RECORDS REVEALED NO DEVIATIONS IN RELATION TO THE REPORTED ERROR. SAMPLES WERE TESTED, ACCORDING TO GBO STANDARD TESTING PROCEDURES, WITH REGARDS TO CORRECT ASSEMBLY, LEVEL MARK, FILLING LEVEL AND DRAW VOLUME ACCORDING TO ISO 6710 'SINGLE USE CONTAINERS FOR VENOUS BLOOD SPECIMEN COLLECTION' AND CLSI GP39-A6 REGULATIONS FOR 'EVACUATED TUBES AND ADDITIVES FOR BLOOD SPECIMEN COLLECTION'. TUBES WERE VERIFIED TO BE CORRECTLY ASSEMBLED AND HAD THE CORRECT FILL GUIDELINE POSITION. GREINER FILL MARK PROVIDES A VISUAL CONTROL OPPORTUNITY FOR THE PHLEBOTOMIST AND FOR THE LAB PERSONNEL TO CHECK FOR PROPER VOLUME COLLECTION OF SPECIMEN. BOTH STANDARDS SPECIFY THE DRAW VOLUME TO BE WITHIN +/- 10% RANGE OF THE NOMINAL FILL VOLUME. 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 · 1

    CUSTOMER STATES TUBES ARE UNDERFILLING. CUSTOMER ALSO ADVICES THAT GLASS DISCARD TUBE IS DRAWN BEFORE COAG TUBE, TUBES ARE ONLY SUPPOSED TO BE DRAWN WITH STRAIGHT NEEDLE AND UNDERFILLED SPECIMENS COME PRIMARILY FROM THE ER (RN DRAWS). THE LOT NUMBER IS THE ONLY ONE THEY HAVE. UNKNOWN IF ISSUE HAS BEEN SEEN IN ANY OTHER LOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    595978 VACUETTE TUBE 3 ML 9NC COAGULATION SODIUM CITRATE 3,2% 13X75 EVACUATED BLOOD COLLECTION TUBE GIM GREINER BIO-ONE NA INC. 454334 B20113CT

    Patients

    Seq Age Sex Outcome Treatment
    1