BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VACUETTE TUBE 3 ML K2E K2EDTA 13X75 LAVENDER CAP-BLACK RING, NON-RIDGED

    MDR report key: 12210920 · Received July 22, 2021

    Report

    Report Number
    1125230-2021-00059
    Event Type
    Malfunction
    Date Received
    July 22, 2021
    Report Date
    August 9, 2021
    Manufacturer
    GREINER BIO-ONE NA INC.
    Product Code
    JKA
    PMA / PMN Number
    K971236
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    NO SAMPLES WERE RECEIVED FOR EVALUATION. WE HAVE NO FURTHER COMPLAINTS ON THIS MATERIAL/BATCH. A REVIEW OF QUALITY, PRODUCTION, AND MAINTENANCE DOCUMENTS SHOWS NO DEVIATIONS IN RELATION TO THE REPORTED ISSUE. THE COMPLAINT CANNOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    COMPLAINT (B)(4). EXACT DATES OF THE DESCRIBED EVENTS COULD NOT BE OBTAINED FROM THE CUSTOMER. SAMPLES FROM THE CUSTOMER WERE JUST RECENTLY RECEIVED AND THE EVALUATION OF SAMPLES AS WELL AS INVESTIGATION OF THE DESCRIBED ISSUE IS STILL IN PROCESS. AS SOON AS THE INVESTIGATION IS COMPLETED A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    CUSTOMER STATES THERE HAVE BEEN AN INCREASED NUMBER CLOTTED SAMPLES; ALMOST DOUBLE FROM LAST YEAR SAME TIME. NUMBER OF OCCURRENCES: (B)(6) 2020 - 59 CLOTTED; (B)(6) 2021 - 103 CLOTTED, (B)(6) 2020 - 61 CLOTTED; (B)(6) 2021 - 94 CLOTTED. CUSTOMER STATES MULTIPLE LOTS AND IS REPORTING THE ONE IN CURRENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1111221 VACUETTE TUBE 3 ML K2E K2EDTA 13X75 LAVENDER CAP-BLACK RING, NON-RIDGED EVACUATED BLOOD COLLECTION TUBE JKA GREINER BIO-ONE NA INC. 454246 B21043RH

    Patients

    Seq Age Sex Outcome Treatment
    1