BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VACUETTE TUBE 2 ML Z NO ADDITIVE 13X75 BLACK CAP-YELLOW RING, NON-RIDGED

    MDR report key: 10803539 · Received November 6, 2020

    Report

    Report Number
    1125230-2020-00044
    Event Type
    Malfunction
    Date Received
    November 6, 2020
    Report Date
    November 18, 2020
    Manufacturer
    GREINER BIO-ONE NA INC.
    Product Code
    JKA
    PMA / PMN Number
    BK050026
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    GBO COMPLAINT NUMBER: (B)(4). NO SAMPLES WERE RECEIVED FOR EVALUATION. WE HAVE NO FURTHER COMPLAINTS ON THE MATERIALS / BATCHES. WE HAVE NO FURTHER INVENTORY OF THE MATERIALS / BATCHES. A CHECK OF QUALITY, PRODUCTION, AND MAINTENANCE DOCUMENTS REVEALED NO DEVIATIONS IN RELATION TO THE REPORTED EVENT. THEREFORE, THE COMPLAINT CANNOT BE DETERMINED.

    Description of Event or Problem · 0

    CUSTOMER STATES THERE ARE PARTICULATES IN THE TUBES.

    Additional Manufacturer Narrative · 1

    GBO COMPLAINT NUMBER: (B)(4). WE HAVE NO FURTHER COMPLAINTS ON THE MATERIAL/BATCH. WE HAVE NO FURTHER INVENTORY OF THE MATERIAL/BATCH. WE ARE WAITING FOR CUSTOMER TO RETURN SAMPLES FOR EVALUATION. WE WILL FILE SUPPLEMENT REPORT IF WE RECEIVE SAMPLES AND HAVE INVESTIGATION REPORT.

    Description of Event or Problem · 1

    CUSTOMER STATES THERE ARE PARTICULATES IN THE TUBES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1262691 VACUETTE TUBE 2 ML Z NO ADDITIVE 13X75 BLACK CAP-YELLOW RING, NON-RIDGED BLOOD COLLECTION TUBES JKA GREINER BIO-ONE NA INC. 454318H, 454318 B200738P, B20073XN, B20033BB

    Patients

    Seq Age Sex Outcome Treatment
    1