BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 7445168 · Received April 19, 2018

    Report

    Report Number
    1917413-2018-00915
    Event Type
    Malfunction
    Date Received
    April 19, 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

    THIS MDR IS CORRECTED TO INCLUDE MULTIPLE PMA / 510(K) NUMBERS. THE ORIGINAL MDR INCLUDED ONLY #K945952. THIS IS CORRECTED TO INCLUDE THE INFORMATION FOR THE ADDITIONAL PMA / 510(K) NUMBER: PMA / 510(K)#: K901449.

    Additional Manufacturer Narrative · 1

    K945952; THERE WERE NO PHOTOS OR CUSTOMER SAMPLES FOR LOT 6154520 TO CONFIRM THIS COMPLAINT. THERE WERE NO MANUFACTURING RELATED ISSUES IDENTIFIED. A CAPA WAS INITIATED TO INVESTIGATE RELATED COMPLAINTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING THE BD VACUTAINER® SODIUM FLUORIDE POTASSIUM OXALATE (FX) BLOOD COLLECTION TUBES, THERE WAS AN INCREASE IN CLOTTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    285648 BD VACUTAINER® SODIUM FLUORIDE POTASSIUM OXALATE (FX) BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. 6154520 50382903679220

    Patients

    Seq Age Sex Outcome Treatment
    1 Other