BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SEDI-40

    MDR report key: 9280376 · Received November 5, 2019

    Report

    Report Number
    2243072-2019-02464
    Event Type
    Malfunction
    Date Received
    November 5, 2019
    Date of Event
    October 21, 2019
    Report Date
    January 28, 2020
    Manufacturer
    BECTON DICKINSON
    Product Code
    JPH
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY BD HAD PERFORMED A TECHNICAL EVALUATION OF THE CUSTOMER'S SEDI-40 INSTRUMENT. THE INSTRUMENT WAS TESTED AND WAS FOUND TO BE FUNCTIONING CORRECTLY. UPON COMPLETION OF THE INSTRUMENT EVALUATION, THE SERVICE TECHNICIAN HAD VERIFIED THAT THE INSTRUMENT WAS OPERATING WITHIN NORMAL PARAMETERS, AS DOCUMENTED IN THE INSTRUMENT SERVICE REPORT. THE INSTRUMENT WAS RUN FOR A SEVERAL DAYS WITH NO ISSUES. H3 OTHER TEXT : SEE SECTION H.10.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT ONE BD SEDI-40 HAS BEEN FOUND EXPERIENCING HARDWARE MALFUNCTION DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: THE MIXER DOESN'T WORK

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING LOCATION FOR THIS PRODUCT IS (B)(4). 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. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT ONE BD SEDI-40 HAS BEEN FOUND EXPERIENCING HARDWARE MALFUNCTION DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: THE MIXER DOESN'T WORK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1071055 BD SEDI-40 ESR INSTRUMENT JPH BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other