BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SEDI-40

    MDR report key: 11637921 · Received April 8, 2021

    Report

    Report Number
    2243072-2021-01031
    Event Type
    Malfunction
    Date Received
    April 8, 2021
    Date of Event
    March 13, 2021
    Report Date
    April 22, 2021
    Manufacturer
    BECTON DICKINSON
    Product Code
    GHC
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 2021-04-06. H6: INVESTIGATION SUMMARY . INSTRUMENT SEDI 40 00211 WAS RETURNED TO THE MANUFACTURER FOR SERVICE WITH RESPECT TO THE REPORTED DEFECT ¿ LLO FLAGGING. THE INSTRUMENT WAS EVALUATED BY VISUAL EXAMINATION AND FUNCTIONAL TESTING AND WAS FOUND TO BE WORKING ACCORDING TO SPECIFICATIONS. THE CALIBRATION WAS FOUND TO BE CORRECT. THE LIKELY CAUSE OF THE LLO FLAGGING IS UNDERFILLED TUBES. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOT, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THERE WERE NO RELATED QUALITY NON-CONFORMANCES DURING MANUFACTURING OF THE PRODUCT. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD SEDI-40 HAD A HARDWARE MALFUNCTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "LOT OF SAMPLES HAVE LLO READINGS."

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD SEDI-40 HAD A HARDWARE MALFUNCTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "LOT OF SAMPLES HAVE LLO READINGS"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    530702 BD SEDI-40 ESR INSTRUMENT GHC BECTON DICKINSON

    Patients

    Seq Age Sex Outcome Treatment
    1