BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® RAPID SERUM TUBE (RST) BLOOD COLLECTION TUBES THROMBIN

    MDR report key: 18994528 · Received March 28, 2024

    Report

    Report Number
    2243072-2024-00469
    Event Type
    Malfunction
    Date Received
    March 28, 2024
    Date of Event
    March 1, 2024
    Report Date
    March 18, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    JKA
    UDI-DI
    50382903687744
    PMA / PMN Number
    K101502
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURING LOCATION FOR THIS PRODUCT IS SEKISUI. THIS SITE IS AN OEM MANUFACTURING SITE. THEREFORE, BD CORPORATE HEADQUARTERS IN FRANKLIN LAKES, NJ HAS BEEN LISTED IN SECTIONS D.3. AND G.1. AND THE FRANKLIN LAKES FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. B3: DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. H.6. INVESTIGATION SUMMARY: "MATERIAL #: 368774, LOT/BATCH #: 220309. BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR EVALUATION. RETENTION SAMPLES FROM LOT NUMBER 220309 COULD NOT BE TESTED DUE TO THE LOT EXPIRING IN MAY 2023. 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 ERRONEOUS POTASSIUM. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. FOR DIALYSIS PATIENTS, THEIR BLOOD MAY HAVE HEPARIN WHICH WILL CAUSE THE RST TUBE TO DELAY COAGULATION. DELAYED COAGULATION CAN LEAD TO ELEVATED POTASSIUM RESULTS. 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 BD VACUTAINER® RAPID SERUM TUBE (RST) BLOOD COLLECTION TUBES, THROMBIN POTASSIUM RESULTS WERE ELEVATED IN HEMODIALYSIS PATIENTS. THERE WAS NO REPORT OF IMPACT TO PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    716550 BD VACUTAINER® RAPID SERUM TUBE (RST) BLOOD COLLECTION TUBES THROMBIN BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON DICKINSON 220309 50382903687744

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown