BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICOLLECT TUBE 0.5 ML K2E K2EDTA LAVENDER CAP, WITH CROSS CUT, SPRAY-DRIED

    MDR report key: 10465734 · Received August 28, 2020

    Report

    Report Number
    8020040-2020-00006
    Event Type
    Malfunction
    Date Received
    August 28, 2020
    Report Date
    September 25, 2020
    Manufacturer
    GREINER BIO-ONE GMBH
    Product Code
    JKA
    PMA / PMN Number
    K063357
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    GBO COMPLAINT NO: (B)(4). WE RECEIVED 100PCS 450480/200109 FOR EVALUATION FROM THE CUSTOMER. WE HAVE NO FURTHER COMPLAINTS ON THE MATERIAL/BATCH. WE HAVE NO FURTHER INVENTORY OF THE MATERIAL/BATCH. CUSTOMER SAMPLES WERE ANALYZED WITH BLOOD AND NO OBSERVATION OF BLOOD CLOTS NOR HEMOLYSIS COULD BE DETECTED. A REVIEW OF THE PRODUCTION DOCUMENTS REVEALED NO DEVIATIONS IN RELATION TO THE REPORTED ISSUES. THE DEVICE IS NOT INTENDED TO BE USED WITH VENOUS OR ARTERIAL BLOOD. HEMOLYSIS CAN OCCUR DURING ALL PRE-ANALYTICAL PHASES AND IS INFLUENCED BY MANY VARIABLES. THEREFORE, THIS COMPLAINT IS NOT JUSTIFIED.

    Description of Event or Problem · 0

    CUSTOMER STATES 2 ISSUES WITH TUBES. SPECIMENS ARE CLOTTING. HEMOLYSIS IS OCCURRING. FOR CLOTTING ISSUE, SPECIMENS ARE BEING MIXED ADEQUATELY PER IFU. FOR HEMOLYSIS, CUSTOMER ADVISES THEY DO NOT BELIEVE SPECIMENS ARE BEING SHAKEN, TUBES ARE BEING FILLED APPROPRIATELY TO FILL MARK +/- 10%. CUSTOMER IS UNSURE OF EXACT NUMBER OF OCCURRENCES. SPECIMENS ARE BEING COLLECTED BY HEEL STICK, ARTERIAL LINES AND ARTERIAL BLOOD DRAWS. FUNNELS ARE BEING USED WITH COLLECTION. MULTIPLE SITES ARE EXPERIENCING THESE ISSUES.

    Additional Manufacturer Narrative · 1

    GBO COMPLAINT: (B)(4). NO PHOTOS, CLARIFICATION OR FURTHER INFORMATION WAS RECEIVED FROM THE CUSTOMER. WE HAVE NOT RECEIVED SUSPECTED DEVICE FOR THE INVESTIGATION. WE DO NOT HAVE FURTHER INVENTORY OR COMPLAINT FOR THIS MATERIAL/BATCH. WE HAVE RECEIVED SAMPLES FROM THE SAME MATERIAL AND LOT FROM THE CUSTOMER. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILLED.

    Description of Event or Problem · 1

    CUSTOMER STATES 2 ISSUES WITH TUBES. SPECIMENS ARE CLOTTING. HEMOLYSIS IS OCCURRING. FOR CLOTTING ISSUE, SPECIMENS ARE BEING MIXED ADEQUATELY PER IFU. FOR HEMOLYSIS, CUSTOMER ADVISES THEY DO NOT BELIEVE SPECIMENS ARE BEING SHAKEN, TUBES ARE BEING FILLED APPROPRIATELY TO FILL MARK +/- 10%. CUSTOMER IS UNSURE OF EXACT NUMBER OF OCCURRENCES. SPECIMENS ARE BEING COLLECTED BY HEEL STICK, ARTERIAL LINES AND ARTERIAL BLOOD DRAWS. FUNNELS ARE BEING USED WITH COLLECTION. MULTIPLE SITES ARE EXPERIENCING THESE ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    933798 MINICOLLECT TUBE 0.5 ML K2E K2EDTA LAVENDER CAP, WITH CROSS CUT, SPRAY-DRIED TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION JKA GREINER BIO-ONE GMBH 450480 200109

    Patients

    Seq Age Sex Outcome Treatment
    1