BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SEDI-40

    MDR report key: 12675320 · Received October 21, 2021

    Report

    Report Number
    2243072-2021-02568
    Event Type
    Malfunction
    Date Received
    October 21, 2021
    Date of Event
    September 21, 2021
    Report Date
    September 30, 2021
    Manufacturer
    BECTON DICKINSON
    Product Code
    JKA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    OEM MANUFACTURER: THE MANUFACTURING LOCATION FOR THIS PRODUCT IS ELITECH. THIS SITE IS AN OEM MANUFACTURING SITE. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. INVESTIGATION SUMMARY: INSTRUMENT SEDI 40 00154 WAS RETURNED TO THE MANUFACTURER FOR SERVICE WITH RESPECT TO THE REPORTED DEFECT ¿ NOT MIXING. THE INSTRUMENT WAS EVALUATED BY VISUAL EXAMINATION AND FUNCTIONAL TESTING AND THE MIXING MOTOR WAS FOUND TO BE FAULTY. THIS MOTOR WAS REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED WHEN USING THE BD SEDI-40 THERE WAS A HARDWARE / SOFTWARE MALFUNCTION FOR ESR INSTRUMENT.THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THE DEVICE "DOESN¿T WANT TO START MIXING. SOMETIMES WHEN MIXING STARTS IT STOP IN THE MIDDLE OF MIXING PROCESS. THERE IS A BROKEN TUBE COVER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1572709 BD SEDI-40 ESR INSTRUMENT JKA BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1