BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SODIUM FLUORIDE POTASSIUM OXALATE

    MDR report key: 7456022 · Received April 24, 2018

    Report

    Report Number
    1917413-2018-01149
    Event Type
    Malfunction
    Date Received
    April 24, 2018
    Date of Event
    February 28, 2017
    Report Date
    June 7, 2018
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    JKA
    UDI-DI
    50382903679220
    PMA / PMN Number
    K945952
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL PMA / 510(K)#: K901449

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR EVALUATION; THEREFORE, THE INVESTIGATION WAS LIMITED. A REVIEW OF THE MANUFACTURING RECORDS WAS COMPLETED FOR THE INCIDENT LOT AND NO ISSUES WERE IDENTIFIED. BD HAS INITIATED A CAPA TO DOCUMENT FURTHER INVESTIGATION AND ROOT CAUSE(S) OF THIS PRODUCT ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD VACUTAINER® SODIUM FLUORIDE 10MG POTASSIUM OXALATE 8 MG (FX) BLOOD COLLECTION TUBES "GLUCOSE-367922-CLOTTING".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299497 BD VACUTAINER® SODIUM FLUORIDE POTASSIUM OXALATE BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. 6216609 50382903679220

    Patients

    Seq Age Sex Outcome Treatment
    1 Other