BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SODIUM FLUORIDE 15MG POTASSIUM OXALATE 12 MG (FX)

    MDR report key: 7537220 · Received May 23, 2018

    Report

    Report Number
    1917413-2018-01335
    Event Type
    Malfunction
    Date Received
    May 23, 2018
    Date of Event
    December 29, 2017
    Report Date
    May 11, 2018
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    JKA
    UDI-DI
    50382903679251
    PMA / PMN Number
    K945952
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PMA / 510(K)# K901449. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD VACUTAINER® SODIUM FLUORIDE 15MG POTASSIUM OXALATE 12 MG (FX) BLOOD COLLECTION TUBES HAD A ADDITIVE ABNORMALITY. NO SERIOUS INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380351 BD VACUTAINER® SODIUM FLUORIDE 15MG POTASSIUM OXALATE 12 MG (FX) BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. 7214683 50382903679251

    Patients

    Seq Age Sex Outcome Treatment
    1 Other