BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER TUBE PST GEL AND LIHE 83 UNITS

    MDR report key: 7717888 · Received July 24, 2018

    Report

    Report Number
    MW5078579
    Event Type
    Malfunction
    Date Received
    July 24, 2018
    Date of Event
    July 5, 2018
    Report Date
    July 19, 2018
    Manufacturer
    BD
    Product Code
    JKA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    WE STARTED USING THE BD LITHIUM HEPARIN TUBES (367962, LOT # 8061753 ON (B)(6) 2018 AND CONTINUED UNTIL (B)(6) 2018) WHEN WE IDENTIFIED THIS PROBLEM. THE BD LITHIUM HEPARIN SEPARATOR TUBES HAVE A POSITIVE BIAS FOR AST OF APPROX 50%. SODIUM'S AND CALCIUM ALSO COULD HAVE A PROBLEM OF SLIGHT POSITIVE BIAS. WHILE ONLY ONE PATIENT IS LISTED ABOVE, WE WILL BE RE-DRAWING BLOOD AND REPEATING TESTS FOR APPROX 205 PATIENTS. AN UNK NUMBER OF PATIENTS RECEIVED ADDITIONAL TESTING (LAB AND IMAGING) AS A RESULT OF THEIR ABNORMAL RESULTS. SEVERAL PHYSICIANS QUESTIONED RESULTS OF PATIENT THAT HAD ROUTINE/PREVIOUS TESTING WHICH INITIATED OUR INVESTIGATION. AFTER DETERMINING THE VACUTAINER TUBE COULD BE THE CAUSE, WE REMOVED THIS PRODUCT WHICH ALL HAD THE SAME LOT NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    558222 BD VACUTAINER TUBE PST GEL AND LIHE 83 UNITS TUBES, VIALS, SYSTEMS, SERUM SEPARATOR JKA BD 8061753

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other