BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ SEDI-40 INSTRUMENT

    MDR report key: 7865449 · Received September 11, 2018

    Report

    Report Number
    2243072-2018-01169
    Event Type
    Malfunction
    Date Received
    September 11, 2018
    Date of Event
    August 21, 2018
    Report Date
    April 3, 2019
    Manufacturer
    BECTON DICKINSON
    Product Code
    GHC
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: INVESTIGATION SUMMARY: BD HAD PERFORMED A TECHNICAL EVALUATION OF THE CUSTOMER'S SEDI-40 INSTRUMENT. IT WAS DETERMINED THAT UPON EVALUATION, THE SERVICE TECHNICIAN HAD VERIFIED THAT THE INSTRUMENT WAS OPERATING WITHIN NORMAL PARAMETERS, AS DOCUMENTED IN THE INSTRUMENT SERVICE REPORT. NO ISSUES RELATING THE CUSTOMER'S OBSERVATION WAS OBSERVED. INVESTIGATION CONCLUSION: BASED ON EVALUATION OF THE CUSTOMER'S INSTRUMENT, NO ISSUES WERE FOUND. ROOT CAUSE DESCRIPTION: A ROOT CAUSE COULD NOT BE DETERMINED. RATIONALE: COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. THE BD BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE OF THE BD¿ SEDI-40 DELIVERS VERY MANY LLO AND LLH MESSAGES EVEN THOUGH THE TUBES ARE FULL AND WELL MIXED BEFORE BEING INSERTED INTO THE INSTRUMENT. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE OF THE BD¿ SEDI-40 DELIVERS VERY MANY LLO AND LLH MESSAGES EVEN THOUGH THE TUBES ARE FULL AND WELL MIXED BEFORE BEING INSERTED INTO THE INSTRUMENT. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    707455 BD¿ SEDI-40 INSTRUMENT ESR INSTRUMENT GHC BECTON DICKINSON N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other