BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SEDI-20

    MDR report key: 8675578 · Received June 6, 2019

    Report

    Report Number
    2243072-2019-01125
    Event Type
    Malfunction
    Date Received
    June 6, 2019
    Date of Event
    May 16, 2019
    Report Date
    July 5, 2019
    Manufacturer
    BECTON DICKINSON
    Product Code
    JKA
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: INVESTIGATION SUMMARY: BD RECEIVED INSTRUMENT FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE INSTRUMENT WAS SENT TO MANUFACTURE TO BE TESTED/EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE WAS NOT OBSERVED AS ALL PRODUCT SPECIFICATIONS WERE MET. ADDITIONALLY, BD WAS UNABLE TO DETERMINE THE SPECIFIC LOT NUMBER ASSOCIATED WITH THIS COMPLAINT. THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED. INVESTIGATION CONCLUSION: BASED ON EVALUATION OF THE CUSTOMER SAMPLES, THE CUSTOMER¿S INDICATED FAILURE MODE FOR BROKEN WITH THE INCIDENT LOT WAS NOT OBSERVED AS ALL SAMPLES MET THE REQUIRED SPECIFICATIONS. ROOT CAUSE DESCRIPTION: BASED ON THE INVESTIGATION, 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. H3 OTHER TEXT : SEE H.10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE OF THE BD SEDI-20 WHEN THE ESR IS ABOVE 30MM/H VALUE IT GIVES LLO INFORMATION FEW TIMES A DAY. THE TUBES WERE CHECKED AND FILLED PROPERLY, PROPERLY BARCODED AS WELL THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FOR ESR ABOVE 30MM/H VALUE IT GIVES LLO INFORMATION FEW TIMES A DAY. TUBES WERE CHECKED AND FILLED PROPERLY, PROPERLY BARCODED AS WELL

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE EVALUATED BY MFR: A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE OF THE BD SEDI-20 WHEN THE ESR IS ABOVE 30MM/H VALUE IT GIVES LLO INFORMATION FEW TIMES A DAY. THE TUBES WERE CHECKED AND FILLED PROPERLY, PROPERLY BARCODED AS WELL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FOR ESR ABOVE 30MM/H VALUE IT GIVES LLO INFORMATION FEW TIMES A DAY. TUBES WERE CHECKED AND FILLED PROPERLY, PROPERLY BARCODED AS WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468041 BD SEDI-20 ESR INSTRUMENT JKA BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other