BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SEDI-40

    MDR report key: 7592040 · Received June 12, 2018

    Report

    Report Number
    2243072-2018-01231
    Event Type
    Malfunction
    Date Received
    June 12, 2018
    Date of Event
    September 27, 2017
    Report Date
    May 21, 2018
    Manufacturer
    BECTON DICKINSON
    Product Code
    GHC
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IN THIS MDR, BD CORPORATE HEADQUARTERS IN (B)(4), NJ HAS BEEN LISTED AS (B)(4) IS AN OEM MANUFACTURING SITE. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. RETURNED TO MANUFACTURER ON: UNKNOWN. (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. DEVICE MANUFACTURE DATE: UNKNOWN. BD RECEIVED THE INSTRUMENT FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE INSTRUMENT WAS EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE WITH THE INCIDENT LOT WAS NOT OBSERVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD SEDI-40 ESR INSTRUMENT WAS DISPLAYING INCORRECT INFORMATION FOR PROPERLY FILLED AND MIXED TUBES. NO SERIOUS INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    436098 BD SEDI-40 ESR INSTRUMENT GHC BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other