BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET

    MDR report key: 18425254 · Received January 2, 2024

    Report

    Report Number
    1024879-2023-00934
    Event Type
    Malfunction
    Date Received
    January 2, 2024
    Date of Event
    December 4, 2023
    Report Date
    January 10, 2024
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    50382903673440
    PMA / PMN Number
    K030573
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY MATERIAL #: 367344. LOT/BATCH#: UNKNOWN . BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR INVESTIGATION. THEREFORE, 30 RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY FUNCTIONAL TESTING, EACH USED TO DRAW 10 VACUTAINER TUBES, AND NO ISSUES WERE OBSERVED RELATING TO SLEEVE LEAKAGE 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 SLEEVE LEAKAGE. 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.

    Additional Manufacturer Narrative · 0

    THERE WERE MULTIPLE 510K NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION IS AS FOLLOWS: G.5. PMA / 510(K)#: K220212. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    REPORT 2 OF 2. IT WAS REPORTED THAT WHILE USING BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET, THERE WAS SAMPLE LEAKAGE INTO THE ONE-USE HOLDER. THIS WAS SEEN IN ONE DEVICE. NO PATIENT IMPACT REPORTED.

    Description of Event or Problem · 0

    REPORT 2 OF 2. IT WAS REPORTED THAT WHILE USING BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET, THERE WAS SAMPLE LEAKAGE INTO THE ONE-USE HOLDER. THIS WAS SEEN IN ONE DEVICE. NO PATIENT IMPACT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1450490 BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) UNKNOWN 50382903673440

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown