BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REGEN¿ THT® NC: 1.0ML

    MDR report key: 7466442 · Received April 26, 2018

    Report

    Report Number
    1917413-2018-00981
    Event Type
    Malfunction
    Date Received
    April 26, 2018
    Date of Event
    November 23, 2016
    Report Date
    September 18, 2018
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    JKA
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORDS WERE REVIEWED FOR BATCH 6182782 WITH NO ISSUES BEING IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE REGEN THT NC: 1.0ML TUBES HAD TOO MUCH ADDITIVE IN THEM.

    Additional Manufacturer Narrative · 1

    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. THERE WAS NO SAMPLE AND/OR PHOTO AVAILABLE PROVIDED FROM THE INCIDENT LOT NUMBER IN SUPPORT OF THIS DEFECT. BASED ON THE INVESTIGATION, A ROOT CAUSE COULD NOT BE DETERMINED WITHIN THE SCOPE OF THIS EVALUATION. HOWEVER, AS THESE TUBES ARE MANUALLY FILLED, THERE IS A POSSIBILITY FOR THE OPERATOR TO IN ADVERTENTLY FILL THE SAME TUBES TWICE. (B)(6).

    Additional Manufacturer Narrative · 1

    DATE RECEIVED BY MANUFACTURER CORRECTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE REGEN¿ THT® NC: 1.0ML TUBES HAD TOO MUCH ADDITIVE IN THEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308243 REGEN¿ THT® NC: 1.0ML BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. 6182782

    Patients

    Seq Age Sex Outcome Treatment
    1 Other