BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VACUETTE TUBE 2 ML K2E K2EDTA 13X75 LAVENDER CAP-WHITE RING, NON-RIDGED

    MDR report key: 10758113 · Received October 29, 2020

    Report

    Report Number
    1125230-2020-00039
    Event Type
    Malfunction
    Date Received
    October 29, 2020
    Report Date
    October 29, 2020
    Manufacturer
    GREINER BIO-ONE NA INC.
    Product Code
    JKA
    PMA / PMN Number
    K971236
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    GBO COMPLAINT NO: (B)(4). CUSTOMER PICTURES WERE RECEIVED. WE HAVE NO FURTHER INVENTORY OF THE MATERIAL/BATCH. WE HAVE NO FURTHER COMPLAINTS ON THE MATERIAL/BATCH. A REVIEW OF QUALITY, PRODUCTION, AND MAINTENANCE DOCUMENTS REVEALED NO DEVIATIONS IN RELATION THE REPORTED EVENT. AN EVALUATION OF THE EXAMPLES IN THE CUSTOMER PICTURES SHOWS THAT THE TWO GBO TUBES APPEAR TO BE ADEQUATELY FILLED, WITHIN THE +/- 10% TOLERANCE. THE COMPLAINT IS CONSIDERED NOT JUSTIFIED.

    Description of Event or Problem · 1

    CUSTOMER STATES TUBES WILL NOT COLLECT MORE THAN 1 ML OF BLOOD PER DRAW. COLLECTION IS PERFORMED WITH A BUTTERFLY NEEDLE AND BD VACUTAINER (PROVIDED PICTURES). THE COLLECTIONS CONSISTS OF 2-10ML EDTA TUBES, THEN THE 2ML EDTA TUBE [454428], FOLLOWED BY A 10 ML PPT TUBE. ALL TUBES COLLECT FULL EXCEPT THE 2ML EDTA [454428].

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1224679 VACUETTE TUBE 2 ML K2E K2EDTA 13X75 LAVENDER CAP-WHITE RING, NON-RIDGED BLOOD COLLECTION TUBES JKA GREINER BIO-ONE NA INC. 454428 B2007355

    Patients

    Seq Age Sex Outcome Treatment
    1