BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VACUETTE 4ML K2E K2EDTA NR LIL/S 13X75

    MDR report key: 10770948 · Received November 2, 2020

    Report

    Report Number
    1125230-2018-00010
    Event Type
    Malfunction
    Date Received
    November 2, 2020
    Report Date
    November 2, 2020
    Manufacturer
    GREINER BIO-ONE NA INC.
    Product Code
    JKA
    PMA / PMN Number
    K971236
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT (B)(4). RECEIVED 50PC 454209/B180435M FOR EVALUATION. RECEIVED CUSTOMER PICTURES. THE ACTUAL SAMPLE (SEEN IN CUSTOMER PICTURES) WAS NOT RECEIVED. WE HAVE NO FURTHER INVENTORY OF THE MATERIAL/BATCH. A CHECK OF QUALITY, PRODUCTION AND MAINTENANCE RECORDS SHOWS NO DEVIATIONS RELATED TO THE REPORTED ISSUE. SAMPLES WERE TESTED, ACCORDING TO GBO STANDARD TESTING PROCEDURES, WITH REGARDS TO CORRECT ASSEMBLY, LEVEL MARK, FILLING LEVEL, 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 GUIDE LINE 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. NO SHORT FILLS COULD BE OBSERVED ON THE SAMPLES. NO DEVIATIONS WITH THE CAP ASSEMBLY COULD BE OBSERVED PRIOR TO, DURING OR AFTER FILLING OF THE TUBES. ALL COMPONENTS (CAP BODIES, RUBBER STOPPERS AND RING PLATES) WERE INTACT AND REMAINED INTACT. THE COMPLAINT COULD NOT BE CONFIRMED.

    Description of Event or Problem · 1

    CUSTOMER STATES THAT TUBES ARE UNDERFILLING. CUSTOMER ALSO STATES WHEN REMOVING A TUBE FROM THE HOLDER, THE RUBBER STOPPER AND RING COME OUT AND GET STUCK IN THE HOLDER, RESULTING IN BLOOD LEAKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1238112 VACUETTE 4ML K2E K2EDTA NR LIL/S 13X75 EVACUATED BLOOD COLLECTION TUBE JKA GREINER BIO-ONE NA INC. 454209 B180435M

    Patients

    Seq Age Sex Outcome Treatment
    1