BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 11015166 · Received December 15, 2020

    Report

    Report Number
    1125230-2020-00076
    Event Type
    Malfunction
    Date Received
    December 15, 2020
    Report Date
    December 15, 2020
    Manufacturer
    GREINER BIO-ONE NA INC.
    Product Code
    GIM
    PMA / PMN Number
    K971221
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT STATEMENT: (B)(4). GBO COULD NOT OBTAIN THE DATE OF THE EVENT FROM THE CUSTOMER. RECEIVED 1 RACK OF 454322/B200638Y FOR EVALUATION. WE HAVE NO FURTHER COMPLAINTS ON THE MATERIAL/BATCH. 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 THEY ARE NOT ABLE TO GET THE VACUUM IN THE TUBES TO FILL TO THE BLACK ARROW (UNDERFILLING). THIS IS OCCURRING EVEN IF USING A DISCARD TUBE. THIS CAUSES SPECIMENS TO BE REJECTED IN HEMATOLOGY. DEVICES INVOLVED INCLUDE STRAIGHT NEEDLES, BUTTERFLY COLLECTION SETS AND SYRINGES. THE PHLEBOTOMISTS ARE USING A DISCARD TUBE ANYTIME THEY USE A BUTTERFLY COLLECTION SET. THEY ARE SECURING THE TUBE WITH THEIR THUMBS UNTIL A TUBE IS FILLED. CUSTOMER ADVISES THEY DO NOT KNOW THE EXACT PERCENTAGE ON TUBES WHICH ARE REJECTED DUE TO UNDERFILLING BUT ESTIMATES IT TO BE LESS THAN 5%. NO PHOTOS AVAILABLE. CUSTOMER IS A NEW USER OF GBO PRODUCTS. TECHNICAL SERVICES PROVIDED CUSTOMER GREINER COAGULATION DRAW VOLUME GUIDE, COAGULATION FILL VOLUMES PER ISO, AND CLSI, IFU, PA PULSE FOR UNDERFILLING TUBES AND TUBE BROCHURE HIGHLIGHTING COAGULATION TUBES. CUSTOMER ADVISED THAT THE LITERATURE TECHNICAL SERVICES PROVIDED HAS MADE A DIFFERENCE BECAUSE THEY HAVE SEEN A DECREASE IN UNDERFILLING ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1476503 VACUETTE TUBE 2 ML 9NC COAGULATION SODIUM CITRATE 3.2% 13X75 EVACUATED BLOOD COLLECTION TUBE GIM GREINER BIO-ONE NA INC. 454322 B200638Y

    Patients

    Seq Age Sex Outcome Treatment
    1