BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 19393812 · Received May 24, 2024

    Report

    Report Number
    1917413-2024-00448
    Event Type
    Malfunction
    Date Received
    May 24, 2024
    Date of Event
    April 26, 2024
    Report Date
    May 6, 2024
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    GIM
    UDI-DI
    30382903678564
    PMA / PMN Number
    BK050036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D2. MEDICAL DEVICE TYPE: ONE ADDITIONAL CODE APPLIES, JKA. G5. PMA/510(K)#: ONE ADDITIONAL CODE APPLIES, K213670. H6. INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES OR PHOTOS IN SUPPORT OF THIS COMPLAINT CATALOG 367856, LOT NUMBER 3289484. 100 RETENTIONS WERE VISUALLY INSPECTED WITH NO ISSUES BEING IDENTIFIED. BD WAS UNABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE BASED ON THE INVESTIGATION COMPLETED. THE DEVICE HISTORY RECORDS WERE REVIEWED WITH NO ISSUES BEING IDENTIFIED. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESS AND FINAL INSPECTIONS COMPLY WITH SPECIFICATION REQUIREMENTS. 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 IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED BLACK FOREIGN MATTER WAS FOUND IN BD VACUTAINER® K2 EDTA (K2E) 5.4MG BLOOD COLLECTION TUBES. THREE SHELFS CARTONS WERE AFFECTED. THE TUBES WERE NOT USED. NO IMPACT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2332453 BD VACUTAINER® K2 EDTA (K2E) 5.4MG BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE GIM BECTON, DICKINSON & CO. (BROKEN BOW) 3289484 30382903678564

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown