BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) BLOOD COLLECTION TUBES

    MDR report key: 15982505 · Received December 14, 2022

    Report

    Report Number
    1917413-2022-00784
    Event Type
    Malfunction
    Date Received
    December 14, 2022
    Date of Event
    October 12, 2022
    Report Date
    January 17, 2023
    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
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER FURTHER EVALUATION OF THE COMPLAINT, IT HAS BEEN DETERMINED THAT THE PREVIOUSLY SUBMITTED REPORT 1917413-2022-00784 WAS SENT IN ERROR. THERE WAS NO REPORT OF SERIOUS INJURY, MEDICAL INTERVENTION, OR REPORTABLE DEVICE MALFUNCTION. THEREFORE THIS IS NOT CONSIDERED TO BE A REPORTABLE MALFUNCTION.

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATED BY MFR: A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) BLOOD COLLECTION TUBES, THE DEVICE EXPERIENCED ERRONEOUS RESULTS RELATED TO HIGH POTASSIUM LEVELS OF 6.5. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: LOT # 2080690 WAS DRAWN ON 10/12. RESULTS WERE 6.5 AND WERE SENT TO REF LAB TO CONFIRM RESULTS. PATIENT C WAS REDRAWN ON 11/21 AND RESULTS 4.6 RESULTS WHICH WERE STATED TO BE NORMAL. CUSTOMER IS ALLEGING ERRONEOUS POTASSIUM RESULTS WITH THE LITHIUM HEPARIN TUBE.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) BLOOD COLLECTION TUBES, THE DEVICE EXPERIENCED ERRONEOUS RESULTS RELATED TO HIGH POTASSIUM LEVELS OF 6.5. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: LOT # 2080690 WAS DRAWN ON 10/12; RESULTS WERE 6.5 AND WERE SENT TO REF LAB TO CONFIRM RESULTS PATIENT C WAS REDRAWN ON 11/21 AND RESULTS 4.6 RESULTS WHICH WERE STATED TO BE NORMAL. CUSTOMER IS ALLEGING ERRONEOUS POTASSIUM RESULTS WITH THE LITHIUM HEPARIN TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2142043 BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) 2080690 50382903679626

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown