BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 12008336 · Received June 16, 2021

    Report

    Report Number
    1125230-2021-00055
    Event Type
    Malfunction
    Date Received
    June 16, 2021
    Report Date
    June 16, 2021
    Manufacturer
    GREINER BIO-ONE NA INC.
    Product Code
    JKA
    PMA / PMN Number
    K971236
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT STATEMENT (B)(4). NO SAMPLES WERE RECEIVED FOR EVALUATION. NO PICTURES WERE RECEIVED. WE HAVE NO FURTHER COMPLAINTS FOR THE MATERIAL/BATCH. WE HAVE NO REMAINING INVENTORY OF THE MATERIAL/BATCH. THE COMPLAINT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    CUSTOMER STATES TUBE IS NOT FILLING PROPERLY. THE TUBE WILL TAKE ONLY 1 ML OF BLOOD WHEN IT IS A 2 ML TUBE TYPE. THE OFFICE TRAILED THIS WITH SALINE AFTER SEEING THIS HAPPENING WITH PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    910470 VACUETTE TUBE 2 ML K2E K2EDTA 13X75 LAVENDER CAP-WHITE RING, NON-RIDGED, USA EVACUATED BLOOD COLLECTION TUBE JKA GREINER BIO-ONE NA INC. 454428 B21023A9

    Patients

    Seq Age Sex Outcome Treatment
    1