BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REGEN¿ THT® NC: 1.0ML

    MDR report key: 7449106 · Received April 20, 2018

    Report

    Report Number
    1917413-2018-00919
    Event Type
    Malfunction
    Date Received
    April 20, 2018
    Date of Event
    November 23, 2016
    Report Date
    April 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 · 1

    MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR THE LOT NUMBER IS AS FOLLOW: MEDICAL DEVICE LOT #: 6153745, MEDICAL DEVICE EXPIRATION DATE: 06/30/2018, DEVICE MANUFACTURE DATE: 06/01/2016. (B)(6). PMA/510(K) #: THERE IS NO 510(K) FOR THIS DEVICE AS IT IS MANUFACTURED OUTSIDE THE US AND NOT SOLD IN THE US. RESULT: BD RECEIVED SAMPLES FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE SAMPLES WERE EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE FOR CITRATE TUBES WITH THE INCIDENT LOT WAS OBSERVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE REGEN¿ THT® NC: 1.0ML WITH MULTIPLE ISSUES WERE NO REPORT OF MEDICAL INTERVENTIONS OR SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291387 REGEN¿ THT® NC: 1.0ML BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. 6182782

    Patients

    Seq Age Sex Outcome Treatment
    1 Other