BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® K2 EDTA (K2E) 10.8MG BLOOD COLLECTION TUBES

    MDR report key: 21913665 · Received April 25, 2025

    Report

    Report Number
    1917413-2025-00522
    Event Type
    Malfunction
    Date Received
    April 25, 2025
    Date of Event
    March 28, 2025
    Report Date
    June 19, 2025
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    GIM
    UDI-DI
    30382903678632
    PMA / PMN Number
    BK230980
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WERE MULTIPLE MEDICAL DEVICE TYPES: D2B: MEDICAL DEVICE TYPE: JKA. THERE WERE MULTIPLE 510K NUMBERS G4: PMA / 510(K)#: 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 FROM LOT NUMBER 4151695 FOR INVESTIGATION. BD RECEIVED TWO PHOTOS FOR INVESTIGATION. VISUAL EVALUATION OF THESE PHOTOS REVEALED AN ADDITIVE ABNORMALITY. THE TUBES HAVE WHITE PARTICLES OF ADDITIVE ON THE INSIDE WALL OF THE TUBE, AND THE SIZE OF THE PARTICLE CANNOT BE DETERMINED WITH THE PHOTO. 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 LOTS, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THIS COMPLAINT HAS BEEN CONFIRMED FOR THE INDICATED FAILURE MODE: ADDITIVE ABNORMALITY. 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® K2 EDTA (K2E) 10.8MG BLOOD COLLECTION TUBES, THERE WAS 1 TUBE WITH AN ADDITIVE ABNORMALITY. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Description of Event or Problem · 0

    IT WAS REPORTED PRIOR TO USING BD VACUTAINER® K2 EDTA (K2E) 10.8MG BLOOD COLLECTION TUBES, THERE WAS 1 TUBE WITH AN ADDITIVE ABNORMALITY. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    392320 BD VACUTAINER® K2 EDTA (K2E) 10.8MG BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE GIM BECTON, DICKINSON & CO. (BROKEN BOW) 4151695 30382903678632

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown