BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SEDI-20

    MDR report key: 9458408 · Received December 12, 2019

    Report

    Report Number
    2243072-2019-02798
    Event Type
    Malfunction
    Date Received
    December 12, 2019
    Date of Event
    November 25, 2019
    Report Date
    March 16, 2020
    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 SUMMARY : BD RECEIVED THE INSTRUMENT FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE EQUIPMENT WAS EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE FOR LLO ERROR WAS OBSERVED. IT WAS IDENTIFIED THAT THE CALIBRATION WAS SLIGHTLY OUT. A DEVICE HISTORY REVIEW COULD NOT BE COMPLETED AS NO BATCH NUMBER WAS PROVIDED. BD IS CONTINUALLY MONITORING COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION IN ORDER TO IDENTIFY EMERGING TRENDS. H3 OTHER TEXT : SEE SECTION H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A INSTRUMENT MALFUNCTION OCCURRED DURING USE WITH A BD SEDI-20. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "SEDI INDICATES LLO EVEN IF TUBE IS FILLED PROPERLY."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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. THE REPORTED LOT# 361545 WAS NOT FOUND FOR THE CATALOG NUMBER. DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. 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 A INSTRUMENT MALFUNCTION OCCURRED DURING USE WITH A BD SEDI-20. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "SEDI INDICATES LLO EVEN IF TUBE IS FILLED PROPERLY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1257870 BD SEDI-20 ESR INSTRUMENT JKA BECTON DICKINSON SEE. H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other