BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 18896127 · Received March 13, 2024

    Report

    Report Number
    1917413-2024-00193
    Event Type
    Malfunction
    Date Received
    March 13, 2024
    Date of Event
    February 21, 2024
    Report Date
    February 23, 2024
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    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

    G.4. PMA / 510(K)#: K213670. D.4. MEDICAL DEVICE TYPE: GIM. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: D.4. MEDICAL DEVICE LOT #: 3194746, D.4. MEDICAL DEVICE EXPIRATION DATE: 20-NOV-2024, H.4. DEVICE MANUFACTURE DATE: 13-JUL-2023; D.4. MEDICAL DEVICE LOT #: 3222718, D.4. MEDICAL DEVICE EXPIRATION DATE: 31-DEC-2024, H.4. DEVICE MANUFACTURE DATE: 10-AUG-2023. H.6. INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR INVESTIGATION. THEREFORE, 90 RETENTION SAMPLES FROM LOT 31947416 AND THE 100 RETENTIONS FROM LOT 3222718 OF BD INVENTORY WERE EVALUATED BY VISUAL EXAMINATION. NO ISSUES WERE OBSERVED RELATING TO FOREIGN MATTER AS ALL SAMPLES MET SPECIFICATIONS. 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 IS UNABLE TO BE CONFIRMED FOR THE INDICATED FAILURE MODE FOREIGN MATTER. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® K2 EDTA (K2E) 5.4MG BLOOD COLLECTION TUBES THERE WERE 300 BLACK DOTS (FOREIGN MATTER) IN THE INNER WALL OF THE TUBE. THERE WAS NO REPORT OF IMPACT TO THE PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1017475 BD VACUTAINER® K2 EDTA (K2E) 5.4MG BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) SEE H.10 30382903678564

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown