BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 11701409 · Received April 21, 2021

    Report

    Report Number
    1125230-2021-00037
    Event Type
    Malfunction
    Date Received
    April 21, 2021
    Report Date
    April 21, 2021
    Manufacturer
    GREINER BIO-ONE NA INC.
    Product Code
    JKA
    PMA / PMN Number
    K971236
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT STATEMENT CO21-2100-198: RECEIVED 1RK 456279/B210137K FOR EVALUATION. RECEIVED CUSTOMER PICTURES. WE HAVE NO FURTHER INVENTORY OF THE MATERIAL/BATCH. WE HAVE NO FURTHER COMPLAINTS ON THE MATERIAL/BATCH. 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. THIS IS CAUSING INSTRUMENT ISSUES. THEY VERIFIED IT WAS WITH A NORMAL VENIPUNCTURE AND NOT A SYRINGE, ETC. THE WHOLE DIVISION IS HAVING THIS ISSUE. THEY ARE ESTIMATING THAT 2.7% ARE OVERFILLING FROM THE ERRORS THEY'VE HAD VS THE AMOUNT OF SPECIMENS THEY PROCESS IN BLOOD BANK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    597073 VACUETTE TUBE 6 ML K2E K2EDTA 13X100 PINK CAP-PINK RING, NON-RIDGED EVACUATED BLOOD COLLECTION TUBE JKA GREINER BIO-ONE NA INC. 456279 B210137K

    Patients

    Seq Age Sex Outcome Treatment
    1