BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VACUETTE TUBE 6 ML K2E K2EDTA 13X100 PINK CAP-PINK RING, NON-RIDGED

    MDR report key: 11694025 · Received April 20, 2021

    Report

    Report Number
    1125230-2021-00035
    Event Type
    Malfunction
    Date Received
    April 20, 2021
    Report Date
    April 20, 2021
    Manufacturer
    GREINER BIO-ONE NA INC.
    Product Code
    JKA
    PMA / PMN Number
    K971236
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT CO21-2100-194 RECEIVED 1RK 456279/B210233F 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 OVERFILLING. THEY STARTED KEEPING A LOG OF THE OVERFILLED TUBES AND NOTICED THEY WERE ALL THE SAME LOT NUMBER AND ALL WERE COMING FROM THE EMERGENCY ROOM. THEY RECEIVED ABOUT 20 SAMPLES OVER THE COURSE OF A WEEK FROM THE EMERGENCY AND ALL WERE OVERFILLED. COLLECTION BY SYRINGE WOULD BE UNLIKELY, AND MOST WERE PROBABLY STRAIGHT NEEDLE. THE LAB DID AN EXPERIMENT USING A URINE STRAW (URINE TRANSFER DEVICE) IN A CUP OF WATER TO ALLOW THE TUBES TO FILL NATURALLY AND THE TUBES ARE CLEARLY OVERFILLING. CUSTOMER PROVIDED PHOTOS FROM THEIR EXPERIMENT. CUSTOMER STATES THAT THE TYPE AND SCREENS ARE RUN ON THE IMMUCOR ECHO V2.0. THE INSTRUMENT GIVES ERROR PICK_FLUID (STATUS 5C00)-FLUID LEVEL TO HIGH ERROR. THE INSTRUMENT DOES NOT PRODUCE RESULTS AND WASTES REAGENTS. THE OVERFILLED TUBES WERE VISUALLY GREATER THAN 10% OVER THE FILL MARK AND CLEARLY VISIBLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    589151 VACUETTE TUBE 6 ML K2E K2EDTA 13X100 PINK CAP-PINK RING, NON-RIDGED EVACUATED BLOOD COLLECTION TUBE JKA GREINER BIO-ONE NA INC. 456279 B210233F

    Patients

    Seq Age Sex Outcome Treatment
    1