BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® K2 EDTA (K2E) 3.6MG BLOOD COLLECTION TUBES

    MDR report key: 20200935 · Received September 12, 2024

    Report

    Report Number
    1917413-2024-00857
    Event Type
    Malfunction
    Date Received
    September 12, 2024
    Date of Event
    August 14, 2024
    Report Date
    October 1, 2024
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    GIM
    UDI-DI
    30382903678410
    PMA / PMN Number
    SEE H11
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D2. ADDITIONAL MEDICAL DEVICE TYPE: JKA G5. MULTIPLE 510K: BK230980, K213670, K231373 A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH ADDITIONAL/CORRECTED INFORMATION: D.9. DEVICE AVAILABLE FOR EVAL: YES. D.9. RETURNED TO MANUFACTURER ON: 23-AUG-2024. INVESTIGATION SUMMARY: BD RECEIVED 15 SAMPLES FOR INVESTIGATION. FIVE (5) CUSTOMER RETURNED SAMPLES WERE EVALUATED BY FUNCTIONAL TESTING AND FACTORS RELATED TO THE INDICATED FAILURE MODE FOR PLATELET CLUMPING WITH THE INCIDENT LOT WAS NOT OBSERVED. ADDITIONALLY, (B)(4) RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY VISUAL EXAMINATION AND NO ISSUES WERE OBSERVED RELATING TO PLATELET CLUMPING AS ALL SAMPLES MET SPECIFICATIONS. COMPLAINTS FOR SAMPLE QUALITY ARE UNDER STATISTICAL CONTROL FOR THE MONTH OF AUGUST 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 PLATELET CLUMPING. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED AFTER USING BD VACUTAINER® K2 EDTA (K2E) 3.6MG BLOOD COLLECTION TUBES, ABOUT 50 TUBES HAD CLUMPED PLATELETS. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Description of Event or Problem · 0

    IT WAS REPORTED AFTER USING BD VACUTAINER® K2 EDTA (K2E) 3.6MG BLOOD COLLECTION TUBES, ABOUT 50 TUBES HAD CLUMPED PLATELETS. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    575233 BD VACUTAINER® K2 EDTA (K2E) 3.6MG BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE GIM BECTON, DICKINSON & CO. (BROKEN BOW) 4137092 30382903678410

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown