BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES

    MDR report key: 7494990 · Received May 8, 2018

    Report

    Report Number
    1024879-2018-02401
    Event Type
    Malfunction
    Date Received
    May 8, 2018
    Date of Event
    July 20, 2017
    Report Date
    September 6, 2018
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    50382903679886
    PMA / PMN Number
    BK050036
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH 7121763 REORDER NUMBER (B)(4). PRODUCT WAS MANUFACTURED AT THE BD SUMTER SITE MAY, 2017. PRODUCT QUALITY IS EVALUATED DURING THE MANUFACTURING PROCESS WITH PRESCRIBED VARIABLE AND ATTRIBUTES INSPECTIONS. ALL INSPECTIONS WERE IN COMPLIANCE WITH REQUIREMENTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES HAD FM.

    Additional Manufacturer Narrative · 1

    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 FM WITH THE INCIDENT LOT WAS OBSERVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES HAD FM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336095 BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) 7121763 50382903679886

    Patients

    Seq Age Sex Outcome Treatment
    1 Other