BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SODIUM FLUORIDE POTASSIUM OXALATE (FX) BLOOD COLLECTION TUBES

    MDR report key: 7536838 · Received May 23, 2018

    Report

    Report Number
    1917413-2018-02389
    Event Type
    Malfunction
    Date Received
    May 23, 2018
    Date of Event
    September 21, 2017
    Report Date
    June 7, 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
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS MDR IS CORRECTED TO INCLUDE MULTIPLE PMA / 510(K) NUMBERS. THE ORIGINAL MDR INCLUDED ONLY #K0945952. THIS IS CORRECTED TO INCLUDE THE INFORMATION FOR THE ADDITIONAL PMA / 510(K) NUMBER: PMA / 510(K)#: K901449.

    Additional Manufacturer Narrative · 1

    BD RECEIVED SAMPLES FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE SAMPLES WERE EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE WITH THE INCIDENT LOT WAS NOT OBSERVED. A REVIEW OF THE MANUFACTURING RECORDS WAS COMPLETED FOR THE INCIDENT LOT AND NO ISSUES WERE IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD VACUTAINER® SODIUM FLUORIDE POTASSIUM OXALATE (FX) BLOOD COLLECTION TUBES WAS "UNDERFILLING".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381848 BD VACUTAINER® SODIUM FLUORIDE POTASSIUM OXALATE (FX) BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. 7016713 50382903679213

    Patients

    Seq Age Sex Outcome Treatment
    1 Other