BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SEDI-40

    MDR report key: 7466599 · Received April 26, 2018

    Report

    Report Number
    2243072-2018-00503
    Event Type
    Malfunction
    Date Received
    April 26, 2018
    Date of Event
    August 22, 2016
    Report Date
    April 13, 2018
    Manufacturer
    BECTON DICKINSON
    Product Code
    JKA
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. NO LOT # PROVIDED. (B)(6). DEVICE MANUFACTURE DATE: UNKNOWN. BD RECEIVED SAMPLES FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE SAMPLES WERE EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE FOR THE DEVICE WAS OBSERVED. HOWEVER, BD WAS UNABLE TO DETERMINE THE SPECIFIC LOT NUMBER ASSOCIATED WITH THIS COMPLAINT. THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED. THE INSTRUMENT WAS RETURNED TO THE MANUFACTURER FOR SERVICE WITH RESPECT TO THE REPORTED DEFECT OF LLO FLAGGING. THE MANUFACTURER WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE ON EXAMINATION OF THE RETURNED INSTRUMENT

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER RECEIVED A LLO FAILURE EVEN THOUGH THE BD SEDI-40 WAS PROPERLY FILLED. HARDWARE/SOFTWARE MALFUNCTION FOR ESR INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310069 BD SEDI-40 ESR INSTRUMENT JKA BECTON DICKINSON

    Patients

    Seq Age Sex Outcome Treatment
    1 Other