BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® EDTA 2K

    MDR report key: 19028155 · Received April 2, 2024

    Report

    Report Number
    1917413-2024-00268
    Event Type
    Malfunction
    Date Received
    April 2, 2024
    Date of Event
    March 5, 2024
    Report Date
    March 8, 2024
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    UDI-DI
    50382903678469
    PMA / PMN Number
    K981013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E1. INITIAL REPORTER FACILITY NAME: (B)(6). H.6. INVESTIGATION SUMMARY: BD RECEIVED ONE SAMPLE AND 2 PHOTOS IN SUPPORT OF THIS COMPLAINT FROM CATALOG 367846, LOT NUMBER 3223314. VISUAL EXAMINATION OF THE SAMPLE AND PHOTOS WAS PERFORMED AND REVEALED EMBEDDED FM IN THE SIDEWALL OF THE TUBE. EMBEDDED FM IS, BY ITS NATURE, ISOLATED FROM ANY SPECIMEN, THEREFORE IT IS A COSMETIC DEFECT. BD WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE WITH THE INVESTIGATION COMPLETED. THE EXACT CAUSE FOR THE CUSTOMER'S FAILURE MODE COULD NOT BE DETERMINED. 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. 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 PRIOR TO USE THAT THE BD VACUTAINER® EDTA 2K HAD EMBEDDED FM. THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1757398 BD VACUTAINER® EDTA 2K BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) 3223314 50382903678469

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown