BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VACUETTE TUBE 3 ML LH LITHIUM HEPARIN SEPARATOR 13X75

    MDR report key: 11703523 · Received April 21, 2021

    Report

    Report Number
    1125230-2021-00042
    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
    K960857
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT STATEMENT CO21-2100-203: NO SAMPLES WERE RECEIVED. RECEIVED CUSTOMER PICTURES. WE HAVE NO FURTHER COMPLAINTS ON THE MATERIAL/BATCH. WE HAVE NO FURTHER INVENTORY OF THE MATERIAL/BATCH. A REVIEW OF QUALITY, PRODUCTION, AND MAINTENANCE RECORDS SHOWS NO DEVIATIONS IN RELATION TO THE REPORTED EVENT. THE COMPLAINT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    CUSTOMER STATES TUBE HAD CHUNKS IN IT. THE TUBE GAVE A "CLOT DETECT" ERROR ON THE AU. IT WAS THEN VISUALLY CHECKED AND THERE WERE CHUNKS FLOATING IN THE PLASMA. THERE WERE SMALL STRANDS AND CHUNK/BLOB IN THE PLASMA. THE CENTRIFUGE IS THE ONE PROVIDED BY BECKMAN FOR THEIR AUTOMATED LINE. THE SPEED IS 3,000 RCF FOR 4 MINUTES. THE TUBES ARE INVERTED THE RECOMMENDED NUMBER OF TIMES AS PER IFU. THE SAMPLE WAS NOT REFRIGERATED BEFORE BEING LOADED ON THE ANALYZER AS IT WAS IN THE MORNING RUN. NO PRODUCT AVAILABLE OF THIS LOT AS THEY WENT INTO A NEW LOT NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    596759 VACUETTE TUBE 3 ML LH LITHIUM HEPARIN SEPARATOR 13X75 EVACUATED BLOOD COLLECTION TUBE JKA GREINER BIO-ONE NA INC. 454247P B200936F

    Patients

    Seq Age Sex Outcome Treatment
    1