BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® EDTA 2K

    MDR report key: 21606300 · Received March 14, 2025

    Report

    Report Number
    1917413-2025-00260
    Event Type
    Malfunction
    Date Received
    March 14, 2025
    Date of Event
    February 13, 2025
    Report Date
    April 14, 2025
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    UDI-DI
    30382903678465
    PMA / PMN Number
    NA
    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). HOSPITAL. 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 WERE UPDATED DUE TO ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVALUATION: YES H.3 DEVICE EVAL BY MANUFACTURER? YES D9: RETURNED TO MANUFACTURER ON: 07-APR-2025. INVESTIGATION SUMMARY BD RECEIVED ONE SAMPLE AND THREE PHOTOS FOR INVESTIGATION. A VISUAL EVALUATION OF THE RETURNED SAMPLE AND PHOTOS REVEALED AN ADDITIVE ABNORMALITY. THE TUBES DISPLAYED WHITE PARTICLES OF ADDITIVE ON THE INSIDE WALL, WHICH WERE GREATER THAN 2MM². THIS ADDITIVE DEPOSIT VISUALLY STANDS OUT AS IT DOES NOT APPEAR LIKE THE TYPICAL DOT PATTERN. 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 BEEN CONFIRMED FOR THE INDICATED FAILURE MODE: ADDITIVE ABNORMALITY. 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 PRIOR TO USING BD VACUTAINER® EDTA 2K A WHITE FOREIGN MATTER WAS FOUND IN 1 TUBE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Description of Event or Problem · 0

    IT WAS REPORTED PRIOR TO USING BD VACUTAINER® EDTA 2K A WHITE FOREIGN MATTER WAS FOUND IN 1 TUBE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1559411 BD VACUTAINER® EDTA 2K BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) 4166432 30382903678465

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown