BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SODIUM FLUORIDE 10MG POTASSIUM OXALATE 8 MG (FX)

    MDR report key: 7427874 · Received April 13, 2018

    Report

    Report Number
    1917413-2018-00789
    Event Type
    Malfunction
    Date Received
    April 13, 2018
    Date of Event
    October 25, 2016
    Report Date
    June 9, 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
    CI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WERE MULTIPLE PMA / 510(K) NUMBERS REPORTED TO BE INVOLVED. THE ORIGINAL MDR INCLUDED THE INFORMATION FOR #K945952. THE CORRECTION IS MADE TO INCLUDE THE ADDITIONAL PMA / 510(K) NUMBER: PMA / 510(K)#: K901449.

    Additional Manufacturer Narrative · 1

    (B)(6). INVESTIGATION: BD HAD NOT RECEIVED SAMPLES, BUT PHOTOS WERE PROVIDED BY THE CUSTOMER FACILITY FOR INVESTIGATION. THE PHOTOS WERE EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE FOR FOREIGN MATTER WITH THE INCIDENT LOT WAS OBSERVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS FOREIGN MATTER INSIDE A BD VACUTAINER® SODIUM FLUORIDE 10MG POTASSIUM OXALATE 8 MG (FX) BLOOD COLLECTION TUBES BEFORE USE. NO INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272278 BD VACUTAINER® SODIUM FLUORIDE 10MG POTASSIUM OXALATE 8 MG (FX) BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. 6029948 50382903679220

    Patients

    Seq Age Sex Outcome Treatment
    1 Other