BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES

    MDR report key: 7569045 · Received June 5, 2018

    Report

    Report Number
    1024879-2018-02203
    Event Type
    Malfunction
    Date Received
    June 5, 2018
    Date of Event
    February 6, 2018
    Report Date
    May 9, 2018
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    50382903679862
    PMA / PMN Number
    BK050036
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH ADDITIONAL LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 7223923, EXPIRATION DATE: 07/31/2018, MANUFACTURE DATE: 08/11/2017. 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. BD HAS INITIATED A CAPA TO DOCUMENT FURTHER INVESTIGATION AND ROOT CAUSE(S) OF THIS PRODUCT ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES HAD "SAMPLE QUALITY / GEL MIGRATION" NO REPORT OF INJURY OR MEDICAL INTERVENTION. NO REPORT OF BLOOD EXPOSURE TO MUCOUS MEMBRANE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410631 BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) 7074711 50382903679862

    Patients

    Seq Age Sex Outcome Treatment
    1 Other