BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 10992464 · Received December 11, 2020

    Report

    Report Number
    1125230-2020-00069
    Event Type
    Malfunction
    Date Received
    December 11, 2020
    Report Date
    December 28, 2020
    Manufacturer
    GREINER BIO-ONE NA INC.
    Product Code
    GIM
    PMA / PMN Number
    K971221
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT GBO (B)(4): RECEIVED 23PC (UNUSED) 454322/B20063QV FOR EVALUATION. SAMPLES WERE TESTED, ACCORDING TO GBO STANDARD TESTING PROCEDURES, WITH REGARDS TO 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'. 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. NO TUBES WERE FOUND TO SHORT FILL AS DESCRIBED BY THE CUSTOMER. THE COMPLAINT COULD NOT BE DUPLICATED.

    Additional Manufacturer Narrative · 1

    COMPLAINT (B)(4). CUSTOMER DID NOT PROVIDE THE DATE OF THE EVENT AND SUFFICIENT INFORMATION AS WELL AS SAMPLES ARE NOT YET AVAILABLE. SAMPLES WERE REQUESTED AND WHEN THE INVESTIGATION IS COMPLETED, WE WILL SUBMIT A SUPPLEMENT REPORT.

    Description of Event or Problem · 1

    CUSTOMER STATES TUBES ARE SHORT FILLING. THIS OCCURS NOT ALWAYS, BUT RANDOMLY. OCCURS WITH COLLECTION USING BUTTERFLIES AND SYRINGE. DISCARD TUBE DRAWN. GBO PRODUCT SPECIALIST HAS PROVIDED TRAINING TO PHLEBOTOMIST THAT IS EXPERIENCING SHORT FILLING. DURING VIRTUAL PRODUCT TRAINING WITH PRODUCT SPECIALIST, PRODUCT SPECIALIST REPORTED THAT THEY TESTED COLLECTING WITH COLORED WATER AND DEVICES INCLUDING BUTTERFLIES AND SYRINGES. DISCARD TUBE WAS DRAWN. EVERY WAY THE PHLEBOTOMIST AND PRODUCT SPECIALIST TRIED, THE RESULTS VARIED AND PROBABLY 30% OF THE TIME FELL BELOW THE BLACK AREA FILL MARK. THE PHLEBOTOMIST MENTIONED THIS IS WHAT SHE FINDS - IT VARIES - SOMETIMES FILLS PROPERLY AND SOMETIMES RIGHT BELOW - EVEN WHEN SHE TAKES ALL THE CORRECT COLLECTION STEPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1459368 VACUETTE TUBE 2 ML 9NC COAGULATION SODIUM CITRATE 3.2% 13X75 EVACUATED BLOOD COLLECTION TUBE GIM GREINER BIO-ONE NA INC. 454322 B20063QV

    Patients

    Seq Age Sex Outcome Treatment
    1