BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® K2 EDTA (K2E) 7.2MG BLOOD COLLECTION TUBES

    MDR report key: 19269347 · Received May 8, 2024

    Report

    Report Number
    1917413-2024-00392
    Event Type
    Malfunction
    Date Received
    May 8, 2024
    Date of Event
    April 11, 2024
    Report Date
    June 5, 2024
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    GIM
    UDI-DI
    30382903678618
    PMA / PMN Number
    BK050036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: MATERIAL #: 367861. LOT/BATCH #: 3222735. BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR INVESTIGATION. THEREFORE, 100 RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY VISUAL EXAMINATION AND NO ISSUES WERE OBSERVED RELATING TO CLOTTING AS ALL SAMPLES MET SPECIFICATIONS. COMPLAINTS FOR SAMPLE QUALITY ARE UNDER STATISTICAL CONTROL FOR THE MONTH OF APRIL 2024. AT THIS TIME, FURTHER TESTING IS NOT INDICATED. 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. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. BD QUALITY WILL CONTINUE TO MONITOR SAMPLE QUALITY COMPLAINTS.

    Additional Manufacturer Narrative · 0

    D.2. MEDICAL DEVICE TYPE: ONE ADDITIONAL CODE APPLIES, JKA G.5. PMA/510(K)#: ONE ADDITIONAL CODE APPLIES, K213670 H3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD VACUTAINER® K2 EDTA (K2E) 7.2MG BLOOD COLLECTION TUBES, MICRO-CLOTTING WAS FOUND IN AN UNSPECIFIED NUMBER OF SAMPLES INTERFERING WITH CBC TEST. SAMPLES NEEDED TO BE RECOLLECTED. NO IMPACT WAS REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD VACUTAINER® K2 EDTA (K2E) 7.2MG BLOOD COLLECTION TUBES, MICRO-CLOTTING WAS FOUND IN AN UNSPECIFIED NUMBER OF SAMPLES INTERFERING WITH CBC TEST. SAMPLES NEEDED TO BE RECOLLECTED. NO IMPACT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    753539 BD VACUTAINER® K2 EDTA (K2E) 7.2MG BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE GIM BECTON, DICKINSON & CO. (BROKEN BOW) 3222735 30382903678618

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown