BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® K2 EDTA (K2E) 5.4MG BLOOD COLLECTION TUBES

    MDR report key: 21034566 · Received December 30, 2024

    Report

    Report Number
    1917413-2024-01328
    Event Type
    Malfunction
    Date Received
    December 30, 2024
    Date of Event
    December 10, 2024
    Report Date
    January 25, 2025
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    GIM
    UDI-DI
    30382903678564
    PMA / PMN Number
    SEE H11
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D2. ADDITIONAL MEDICAL DEVICE TYPE: JKA. E1. INITIAL REPORTER ADDRESS: (B)(6). G5. MULTIPLE 510(K): 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

    INVESTIGATION SUMMARY BD HAD NOT RECEIVED ANY SAMPLES FOR INVESTIGATION. A TOTAL OF 100 RETAINED SAMPLES WERE INSPECTED, WITH NO ISSUES IDENTIFIED. ADDITIONALLY, 10 RETAINED SAMPLES WERE INSPECTED, AND NO VISIBLE DEFECTS WERE FOUND. FUNCTIONAL TESTS WERE PERFORMED ON THESE 10 RETAINED SAMPLES, AND ALL TUBES WERE WITHIN SPECIFICATION LIMITS. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOT, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THIS COMPLAINT HAS NOT BEEN CONFIRMED FOR THE INDICATED FAILURE MODE: DRAW VOLUME- UNDERFILL. NO DEFINITIVE ROOT CAUSE COULD BE ESTABLISHED FOR THE REPORTED DEFECT. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR THE IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD VACUTAINER® K2 EDTA (K2E) 5.4MG BLOOD COLLECTION TUBES, ONE (1) TUBE UNDERFILLED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD VACUTAINER® K2 EDTA (K2E) 5.4MG BLOOD COLLECTION TUBES, ONE (1) TUBE UNDERFILLED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2429568 BD VACUTAINER® K2 EDTA (K2E) 5.4MG BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE GIM BECTON, DICKINSON & CO. (BROKEN BOW) 4137136 30382903678564

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown