BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SODIUM FLUORIDE: 3 MG. NA2 EDTA: 6MG

    MDR report key: 19110996 · Received April 15, 2024

    Report

    Report Number
    1917413-2024-00318
    Event Type
    Malfunction
    Date Received
    April 15, 2024
    Date of Event
    March 18, 2024
    Report Date
    March 29, 2024
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    UDI-DI
    30382903675877
    PMA / PMN Number
    K901449
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES, BUT 2 PHOTOS WERE PROVIDED FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE INDICATED FAILURE MODE FOR UNDERFILL WAS OBSERVED. ADDITIONALLY, RETENTION SAMPLES FROM BD INVENTORY WERE VISUALLY INSPECTED WITH NO ISSUES IDENTIFIED. FURTHER FUNCTIONAL TESTING WAS ALSO PERFORMED AND ALL TUBES TESTED 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. THERE WERE NO RELATED QUALITY ISSUES DURING MANUFACTURING OF THE PRODUCT. THIS COMPLAINT HAS BEEN CONFIRMED FOR THE INDICATED FAILURE MODE, UNDERFILL. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: D.4. MEDICAL DEVICE LOT #:3016622. D.4. MEDICAL DEVICE EXPIRATION DATE: 31-MAY-2024. H.4. DEVICE MANUFACTURE DATE: 16-JAN-2023. D.4. MEDICAL DEVICE LOT #:3194727. D.4. MEDICAL DEVICE EXPIRATION DATE: 30-NOV-2024. H.4. DEVICE MANUFACTURE DATE: 13-JUL-2023. D.4. MEDICAL DEVICE LOT #: 3222712 D.4. MEDICAL DEVICE EXPIRATION DATE: 31-DEC-2024 H.4. DEVICE MANUFACTURE DATE: 10-AUG-2023.

    Description of Event or Problem · 0

    IT WAS REPORTED TUBES WERE UNDERFILLING DURING USE OF THE BD VACUTAINER® SODIUM FLUORIDE: 3 MG. NA2 EDTA: 6MG TUBES. SAMPLES WERE RE-COLLECTED. THERE WAS NO REPORT OF IMPACT TO THE PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1339904 BD VACUTAINER® SODIUM FLUORIDE: 3 MG. NA2 EDTA: 6MG BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) SEE H.10 30382903675877

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown