BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SEDI-40

    MDR report key: 13172396 · Received January 5, 2022

    Report

    Report Number
    2243072-2021-03040
    Event Type
    Malfunction
    Date Received
    January 5, 2022
    Date of Event
    December 13, 2021
    Report Date
    January 21, 2022
    Manufacturer
    BECTON DICKINSON
    Product Code
    JKA
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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: NA. 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: UNKNOWN.

    Additional Manufacturer Narrative · 0

    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: NA. 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: UNKNOWN.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.9. DEVICE AVAILABLE FOR EVAL?: YES. D.9. RETURNED TO MANUFACTURER ON: 1/10/2022. H.6. INVESTIGATION: INSTRUMENT SEDI 40 19-42018 WAS RETURNED TO THE MANUFACTURER FOR SERVICE WITH RESPECT TO THE REPORTED DEFECT ¿ NOT MIXING. THE INSTRUMENT WAS EVALUATED BY VISUAL EXAMINATION AND FUNCTIONAL TESTING AND IT WAS FOUND THAT THE TIMING BELT BECAME UNSEATED. THE BELT AND ITS SPROCKETS WERE RESEATED. AFTER REPAIR THE INSTRUMENT PASSED ALL FURTHER QUALITY CHECKS. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT THE BD SEDI-40 HAS BEEN FOUND EXPERIENCING A HARDWARE MALFUNCTION. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: MIXER DOES NOT WORK.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT THE BD SEDI-40 HAS BEEN FOUND EXPERIENCING A HARDWARE MALFUNCTION. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: MIXER DOES NOT WORK.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT THE BD SEDI-40 HAS BEEN FOUND EXPERIENCING A HARDWARE MALFUNCTION. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: MIXER DOES NOT WORK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74274 BD SEDI-40 ESR INSTRUMENT JKA BECTON DICKINSON

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown