BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEDI-40 INSTR.

    MDR report key: 15412636 · Received September 13, 2022

    Report

    Report Number
    2243072-2022-01496
    Event Type
    Malfunction
    Date Received
    September 13, 2022
    Date of Event
    August 17, 2022
    Report Date
    November 30, 2022
    Manufacturer
    BECTON DICKINSON
    Product Code
    JKA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    OEM MANUFACTURER: THE MANUFACTURING LOCATION FOR THIS PRODUCT IS ELITECH. THIS SITE IS AN OEM MANUFACTURING SITE. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE FRANKLIN LAKES FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. 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.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVALUATION: YES, RETURNED TO MANUFACTURER ON: 2022-11-30. H.6. INVESTIGATION SUMMARY: INSTRUMENT SEDI 40 00142 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 DEVICE WAS NOT MIXING PROPERLY. A PLEXIGLASS STRIP AND FLAT CABLE WERE REPLACED. AFTER REPAIR THE INSTRUMENT PASSED ALL FURTHER QUALITY CHECKS.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING SEDI-40 INSTR. THAT THE DEVICE DOES NOT MIX. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE DEVICE DOES NOT MIX AND THEN STOPS, IT DOES NOT PROCESS THE SAMPLES.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING SEDI-40 INSTR. THAT THE DEVICE DOES NOT MIX. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE DEVICE DOES NOT MIX AND THEN STOPS, IT DOES NOT PROCESS THE SAMPLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2580170 SEDI-40 INSTR. UNKNOWN JKA BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown