BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SODIUM FLUORIDE BLOOD COLLECTION TUBES

    MDR report key: 7427952 · Received April 13, 2018

    Report

    Report Number
    1917413-2018-00733
    Event Type
    Malfunction
    Date Received
    April 13, 2018
    Date of Event
    November 14, 2016
    Report Date
    April 11, 2018
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    JKA
    UDI-DI
    50382903679213
    PMA / PMN Number
    K945952
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR EVALUATION; THEREFORE, THE INVESTIGATION WAS LIMITED. ADDITIONALLY, BD WAS UNABLE TO DETERMINE THE SPECIFIC LOT NUMBER ASSOCIATED WITH THIS COMPLAINT. THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED. . ADDITIONAL 510K: K901449.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING USE OF THE BD VACUTAINER® SODIUM FLUORIDE BLOOD COLLECTION TUBES THE ¿CUSTOMER FOUND OVER 50% TUBES HAD ISSUE OF HEMOLYSIS. AFTER TRAINING, CUSTOMER DRAW BLOOD WITH STANDARD PROCESS, STILL CAME OUT ISSUE OF HEMOLYSIS.¿ THERE WAS NO REPORT OF INJURY OR FURTHER MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272904 BD VACUTAINER® SODIUM FLUORIDE BLOOD COLLECTION TUBES BLOOD COLLECTION TUBE JKA BECTON, DICKINSON & CO. 4255670 50382903679213

    Patients

    Seq Age Sex Outcome Treatment
    1 Other