BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARIN BLOOD TUBES

    MDR report key: 14607800 · Received June 6, 2022

    Report

    Report Number
    1917413-2022-00305
    Event Type
    Malfunction
    Date Received
    June 6, 2022
    Date of Event
    May 20, 2022
    Report Date
    May 25, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    UDI-DI
    50382903679626
    PMA / PMN Number
    K945952
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INVESTIGATION SUMMARY: MAT: 367962. LOT: 2018937. NO CUSTOMER SAMPLES AND NO PHOTOS WERE RECEIVED IN SUPPORT OF THIS COMPLAINT. THEREFORE, 10 PRODUCTION LOT IN-HOUSE RETENTION TUBES FROM THE BD INVENTORY WERE INSPECTED AND FUNCTIONALLY TESTED AND THE CUSTOMER'S INDICATED FAILURE MODE OF UNDERFILL WAS NOT OBSERVED. BD WAS UNABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE NO SAMPLES WERE RECEIVED, AND THE DEFECT WAS NOT OBSERVED IN THE RETENTION SAMPLE TESTING. THE DEVICE HISTORY RECORDS WERE REVIEWED WITH NO ISSUES BEING IDENTIFIED. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESS AND FINAL INSPECTIONS COMPLY WITH SPECIFICATION REQUIREMENTS. THE QUANTITY OF BLOOD DRAWN INTO EVALUATED TUBES VARIES WITH ALTITUDE, AMBIENT TEMPERATURE, BAROMETRIC PRESSURE, TUBE AGE, VENOUS PRESSURE, AND FILLING TECHNIQUE. 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 IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARIN N (LH) 83 UNITS BLOOD COLLECTION TUBES HAVE NO VACUUM THUS RESULTING IN DRAW VOLUME OF TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "MATERIAL NO. 367962 BATCH NO. 2018937. IT WAS REPORTED BY THE CUSTOMER THAT TUBES HAVE NO VACUUM THUS RESULTING IN DRAW VOLUME OF TUBES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1074369 BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARIN BLOOD TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) 367962 2018937 50382903679626

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown