BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 7598930 · Received June 13, 2018

    Report

    Report Number
    1917413-2018-01731
    Event Type
    Malfunction
    Date Received
    June 13, 2018
    Date of Event
    May 1, 2016
    Report Date
    May 25, 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
    MY
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PMA / 510(K)# K901449. RESULTS: BD RECEIVED SAMPLES FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THIS COMPLAINT IS CONFIRMED TO BE WITHIN THE SCOPE OF A KNOWN ISSUE. QUALITY HAS PREVIOUSLY REVIEWED, EVALUATED AND INVESTIGATED THIS FAILURE MODE. NO FURTHER ACTION IS REQUIRED AT THIS TIME. BASED ON EVALUATION OF THE COMPLAINT INFORMATION, THIS COMPLAINT MEETS THE CRITERIA FOR A PREVIOUSLY INVESTIGATED COMPLAINT; REFERENCE (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD VACUTAINER® SODIUM FLUORIDE POTASSIUM OXALATE (FX) BLOOD COLLECTION TUBES HAD LOW DRAW. NO SERIOUS INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441971 BD VACUTAINER® SODIUM FLUORIDE POTASSIUM OXALATE (FX) BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. 5041525 50382903679213

    Patients

    Seq Age Sex Outcome Treatment
    1 Other