BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICROTAINER® MAP MICROTUBE FOR AUTOMATED PROCESS K2 EDTA

    MDR report key: 12639746 · Received October 15, 2021

    Report

    Report Number
    1917413-2021-00909
    Event Type
    Malfunction
    Date Received
    October 15, 2021
    Date of Event
    September 15, 2021
    Report Date
    December 8, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    UDI-DI
    50382903637060
    PMA / PMN Number
    K093972
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY : BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR EVALUATION. THEREFORE, RETENTION SAMPLES OF THE INCIDENT LOT WERE SELECTED FROM BD INVENTORY FOR EVALUATION AND UPON COMPLETION, NO ISSUES RELATING TO CLOTTING WERE OBSERVED. BD WAS UNABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (CLOTTING) BECAUSE THE DEFECT WAS NOT EVIDENT IN THE TESTING OF THE COMPLAINT LOT SAMPLES. ALL SAMPLES (RETAINS AND CONTROLS) DEMONSTRATED CLINICALLY ACCEPTABLE PERFORMANCE FOR ALL VISUAL OBSERVATIONS EVALUATED. LABORATORY ANALYSIS OF SAMPLES INDICATED THAT THESE TUBES PERFORMED AS EXPECTED. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOT, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THERE WERE NO RELATED QUALITY ISSUES DURING MANUFACTURING OF THE PRODUCT. THIS COMPLAINT IS UNABLE TO BE CONFIRMED FOR THE INDICATED FAILURE MODE CLOTTING. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD MICROTAINER® MAP MICROTUBE FOR AUTOMATED PROCESS K2 EDTA 1.0 MG, THE DEVICE EXPERIENCED CLOTTING/MICRO CLOTS/FIBRIN CLOTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: IT WAS REPORTED THAT THE TUBES ARE CLOTTING. WE ARE CURRENTLY USING THE BD MAP MICROTUBE IN OUR NICU AND WE HAVE HAD GREAT DEAL OF CLOTTED SPECIMENS THIS WEEK. WE HAVE PULLED SOME OF THE TUBES OUT OF CIRCULATION (LOT # 1040043) BUT WE ARE NOW HAVING CLOTTED SPECIMENS WITH A DIFFERENT LOT.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED WHEN USING THE BD MICROTAINER® MAP MICROTUBE FOR AUTOMATED PROCESS K2 EDTA 1.0 MG, THE DEVICE EXPERIENCED CLOTTING/MICRO CLOTS/FIBRIN CLOTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: IT WAS REPORTED THAT THE TUBES ARE CLOTTING. WE ARE CURRENTLY USING THE BD MAP MICROTUBE IN OUR NICU AND WE HAVE HAD GREAT DEAL OF CLOTTED SPECIMENS THIS WEEK. WE HAVE PULLED SOME OF THE TUBES OUT OF CIRCULATION (LOT # 1040043) BUT WE ARE NOW HAVING CLOTTED SPECIMENS WITH A DIFFERENT LOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1538958 BD MICROTAINER® MAP MICROTUBE FOR AUTOMATED PROCESS K2 EDTA BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) 363706 1040043 50382903637060

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown