BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VACUETTE TUBE 2 ML 9NC COAGULATION SODIUM CITRATE 3.2%

    MDR report key: 11703625 · Received April 21, 2021

    Report

    Report Number
    1125230-2021-00040
    Event Type
    Malfunction
    Date Received
    April 21, 2021
    Report Date
    April 21, 2021
    Manufacturer
    GREINER BIO-ONE NA INC.
    Product Code
    GIM
    PMA / PMN Number
    K971221
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT STATEMENT CO21-2100-206: NO SAMPLES WERE RECEIVED FOR EVALUATION. NO CUSTOMER PICTURES WERE RECEIVED. NO BATCH NUMBERS WERE PROVIDED BY THE CUSTOMER. UNFORTUNATELY, WITHOUT BASIC INFORMATION, A THOROUGH INVESTIGATION IS NOT POSSIBLE. THE COMPLAINT IS CLOSED AS CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    CUSTOMER STATES THE VACUUM WOULD NOT FILL THE TUBE TO AN ACCEPTABLE LEVEL. THEY HAVE HAD TO REDRAW SEVERAL PATIENTS. THEY PUT ON A NEW TUBE AND HAVE THE SAME PROBLEM. THE TUBES NEVER FILL TO THE MIDDLE OF THE ARROW ON THE TUBE LIKE THEY ARE SUPPOSED. EVEN IF THEY DO FILL ENOUGH FOR USE IT IS RIGHT TO THE BOTTOM OF THE ARROW. THE TUBES ARE STILL WELL WITHIN THE EXPIRATION DATE. THEY HAVE SEEN THIS WITH MULTIPLE LOTS ESPECIALLY WITHIN 1 TO 2 MONTHS OF EXPIRATION. THE ISSUES ARE BEING SEEN WHEN COLLECTING WITH BD ECLIPSE NEEDLES WITH TUBE HOLDER AND WITH GREINER NEEDLES WITH TUBE HOLDER. YES, A DISCARD TUBE IS DRAWN BEFORE COAGULATION AS THEY UNDERSTAND THE AIR IN THE TUBING HAS TO BE REMOVED PRIOR TO COLLECTION TUBE. THE TUBES ARE FILLING FAR ENOUGH BELOW THE ARROW THAT THE TUBES ARE REJECTED FOR TESTING. THEY UNDERSTAND THAT ANYWHERE WITHIN THE TRIANGLE IS ACCEPTABLE. THESE TUBES ARE NOT FILLING UP TO THE BOTTOM OF THE ARROW. WHEN ASKED IF THE PHLEBOTOMISTS ARE HOLDING THE TUBE IN THE HOLDER WITH THEIR THUMB UNTIL THE TUBE IS COMPLETELY FILLED AS PER IFU, CUSTOMER RESPONDED THIS IS SOMETHING THEY WILL WORK ON WITH STAFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    596762 VACUETTE TUBE 2 ML 9NC COAGULATION SODIUM CITRATE 3.2% EVACUATED BLOOD COLLECTION TUBE GIM GREINER BIO-ONE NA INC. 454322

    Patients

    Seq Age Sex Outcome Treatment
    1