BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES

    MDR report key: 9446055 · Received December 10, 2019

    Report

    Report Number
    1024879-2019-02102
    Event Type
    Malfunction
    Date Received
    December 10, 2019
    Date of Event
    November 22, 2019
    Report Date
    February 3, 2020
    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
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR EVALUATION. BD ACKNOWLEDGES THE CUSTOMER'S EXPERIENCE REGARDING THE INDICATED FAILURE MODE FOR ERRONEOUS RESULTS WITH THE INCIDENT LOT. A REVIEW OF THE MANUFACTURING RECORDS WAS COMPLETED FOR THE INCIDENT LOT AND NO ISSUES WERE IDENTIFIED. BD TECHNICAL SERVICES PROVIDED TROUBLESHOOTING WITH THE CUSTOMER.

    Description of Event or Problem · 0

    MATERIAL NO. 367986. BATCH NO. 9242155. IT WAS REPORTED THAT AFTER USE OF THE BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES THERE WAS AN ISSUE WITH ERRONEOUS RESULTS. THE PROLACTIN RESULTS WERE HIGH. 2 OF 3: PATIENT 2. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PROLACTIN RESULTS WERE HIGH. PATIENTS HAVE NOT BEEN RE-DRAWN.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    MATERIAL NO. 367986, BATCH NO. 9242155. IT WAS REPORTED THAT AFTER USE OF THE BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES THERE WAS AN ISSUE WITH ERRONEOUS RESULTS. THE PROLACTIN RESULTS WERE HIGH. 2 OF 3: PATIENT 2. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PROLACTIN RESULTS WERE HIGH. PATIENTS HAVE NOT BEEN RE-DRAWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1243375 BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) 367986 9242155 50382903679862

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Other