BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SEDI-40

    MDR report key: 15280579 · Received August 24, 2022

    Report

    Report Number
    2243072-2022-01370
    Event Type
    Malfunction
    Date Received
    August 24, 2022
    Date of Event
    July 28, 2022
    Report Date
    November 17, 2022
    Manufacturer
    BECTON DICKINSON
    Product Code
    JKA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    OEM MANUFACTURER: 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. INITIAL REPORTER FACILITY NAME: (B)(6). MEDICAL 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.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVALUATION: YES. D9: RETURNED TO MANUFACTURER ON: 2022-10-14. H.6. INVESTIGATION SUMMARY: INSTRUMENT SEDI 40 19-42017 WAS RETURNED TO THE MANUFACTURER FOR SERVICE WITH RESPECT TO THE REPORTED DEFECT ¿ NOT DETECTING TUBES. THE INSTRUMENT WAS EVALUATED BY VISUAL EXAMINATION AND FUNCTIONAL TESTING AND IT WAS FOUND THAT THE INSTRUMENT WAS MALFUNCTIONING. VARIOUS COMPONENTS WERE REPLACED SUCH AS CABLES BUSHINGS, AND THE COVER PLATE. AFTER REPAIR THE INSTRUMENT PASSED ALL FURTHER QUALITY CHECKS.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO CORRECTED INFORMATION: B.5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT BD SEDI-40 WAS EXPERIENCING HARDWARE ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE PROBLEM CONCERNS THE READING OF THE SAMPLES FOR POSITIONS 1-10: AFTER SCANNING THE TESTED SAMPLE AND ASSIGNING IT TO ITS POSITION, AND THEN CLOSING THE COVER, THE DEVICE STOPS SEEING THE GIVEN SAMPLES, DOES NOT READ THE SAMPLE AND THE DISPLAY SHOWS "X"." D.1 BRAND NAME: BD SEDI-40. D.2.COMMON DEVICE NAME: ESR INSTRUMENT. D.4.UNIQUE DEVICE NUMBER: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT UNKNOWN BD® BLOOD COLLECTION TUBE IS HAVING HARDWARE ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE PROBLEM CONCERNS THE READING OF THE SAMPLES FOR POSITIONS 1-10: AFTER SCANNING THE TESTED SAMPLE AND ASSIGNING IT TO ITS POSITION, THEN CLOSING THE COVER, THE DEVICE STOPS SEEING THE GIVEN SAMPLES, DOES NOT READ THE SAMPLE, AND THE DISPLAY SHOWS "X".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT UNKNOWN BD® BLOOD COLLECTION TUBE IS HAVING HARDWARE ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE PROBLEM CONCERNS THE READING OF THE SAMPLES FOR POSITIONS 1-10: AFTER SCANNING THE TESTED SAMPLE AND ASSIGNING IT TO ITS POSITION, AND THEN CLOSING THE COVER, THE DEVICE STOPS SEEING THE GIVEN SAMPLES, DOES NOT READ THE SAMPLE AND THE DISPLAY SHOWS "X."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD SEDI-40 WAS EXPERIENCING HARDWARE ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE PROBLEM CONCERNS THE READING OF THE SAMPLES FOR POSITIONS 1-10: AFTER SCANNING THE TESTED SAMPLE AND ASSIGNING IT TO ITS POSITION, AND THEN CLOSING THE COVER, THE DEVICE STOPS SEEING THE GIVEN SAMPLES, DOES NOT READ THE SAMPLE AND THE DISPLAY SHOWS "X"."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472358 BD SEDI-40 ESR INSTRUMENT JKA BECTON DICKINSON

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown