BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARIN BLOOD COLLECTION TUBES

    MDR report key: 20622303 · Received November 6, 2024

    Report

    Report Number
    1917413-2024-01026
    Event Type
    Malfunction
    Date Received
    November 6, 2024
    Date of Event
    October 8, 2024
    Report Date
    October 18, 2024
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    UDI-DI
    30382903679608
    PMA / PMN Number
    K945952
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR EVALUATION. THEREFORE, 100 RETENTION SAMPLES FROM EACH LOT FROM BD INVENTORY WERE EVALUATED BY VISUAL EXAMINATION AND THE ISSUE RELATING TO AIR BUBBLES IN GEL WAS OBSERVED IN LOT 4073050. AIR BUBBLES IN GEL WAS NOT OBSERVED IN LOT 4102681 AND NEITHER LOT WAS OBSERVED TO HAVE FOREIGN MATTER. 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 AIR BUBBLES IN GEL FOR LOT 4073050. THIS COMPLAINT HAS NOT BEEN CONFIRMED FOR AIR BUBBLES IN GEL FOR LOT 4102681, AND NOT CONFIRMED FOR FOREIGN MATTER IN BOTH LOTS. 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 PRIOR TO USING BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARIN BLOOD COLLECTION TUBES THERE WAS GEL BUBBLES IN THE SEPARATOR OF 449 TUBES AND FOREIGN MATTER IN 145 TUBES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2133246 BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARIN BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) 4102681 30382903679608

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown