BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ SEDI-40

    MDR report key: 8391093 · Received March 5, 2019

    Report

    Report Number
    2243072-2019-00395
    Event Type
    Malfunction
    Date Received
    March 5, 2019
    Date of Event
    November 14, 2018
    Report Date
    April 10, 2019
    Manufacturer
    BECTON DICKINSON
    Product Code
    JPH
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 AND THE LEVEL TOO LOW ERROR WAS OBSERVED. IT WAS DETERMINED THAT THE MALFUNCTION WAS ATTRIBUTED TO A BROKEN PLEXIGLAS PLATE IN THE TUBE LID. UPON COMPLETION OF THE INSTRUMENT EVALUATION AND SUBSEQUENT REPAIR, THE SERVICE TECHNICIAN HAD VERIFIED THAT THE INSTRUMENT WAS OPERATING WITHIN NORMAL PARAMETERS, AS DOCUMENTED IN THE INSTRUMENT SERVICE REPORT. INVESTIGATION CONCLUSION: BASED ON EVALUATION OF THE CUSTOMER'S INSTRUMENT, THE LEVEL TOO LOW ERROR WAS OBSERVED. ROOT CAUSE DESCRIPTION: THE ROOT CAUSE WAS DETERMINED TO BE A BROKEN PLEXIGLAS PLATE IN THE TUBE LID. 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 AN ERROR MESSAGE OF LLOW LEVEL TOO LOW EVEN THOUGH THE TUBE ARE FILLED TO PROPER LEVEL. THIS HAS BEEN HAPPENING FOR THE LAST FOUR MONTHS.

    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: N/A. (B)(6). 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: N/A.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE OF THE BD¿ SEDI-40 AN ERROR MESSAGE OF LOW LEVEL TOO LOW EVEN THOUGH THE TUBE ARE FILLED TO PROPER LEVEL. THIS HAS BEEN HAPPENING FOR THE LAST FOUR MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185901 BD¿ SEDI-40 ESR INSTRUMENT JPH BECTON DICKINSON N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other