BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BACTEC¿ FX, INSTRUMENT TOP, PACKAGED

    MDR report key: 12080657 · Received June 28, 2021

    Report

    Report Number
    1119779-2021-01066
    Event Type
    Malfunction
    Date Received
    June 28, 2021
    Date of Event
    April 18, 2021
    Report Date
    October 29, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    MDB
    UDI-DI
    00382904413859
    PMA / PMN Number
    K915796
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE RECEIVED BY MANUFACTURER: 2021-06-25.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY CUSTOMER REPORTED A FAILURE ON A BD BACTEC FX TOP INSTRUMENT (P/N 441385, S/N FT2634). CUSTOMER INDICATED ABOUT THE BROKEN VIAL LEAKED IN THE STATION. A BD REMOTE ASSISTANCE COMMUNICATED WITH THE CUSTOMER AND CONFIRMED THAT THE CUSTOMER CLEANED THE LIQUID WITH BLEACH SOLUTION AND FOLLOWED THE DECONTAMINATION PROCEDURE. THE INSTRUMENT IS DEEMED FUNCTIONAL FOR CUSTOMER¿S USE. THIS IS AN UNCONFIRMED FAILURE OF THE BD PRODUCT. DHR REVIEW IS NOT REQUIRED FOR THIS COMPLAINT. THE COMPLAINT WAS EVALUATED VIA OTHER ELEMENTS OF THE INVESTIGATION. THE RESULTS OF THIS EVALUATION HAVE NOT IDENTIFIED ANY NEW HAZARDS, NEW RISKS, OR SPECIFIC TRENDS. SERVICE HISTORY RECORD REVIEW REVEALED NO PREVIOUS COMPLAINTS FOR THIS ISSUE.BD QUALITY DID NOT RECEIVE ANY RETURNED PARTS OR INSTRUMENT FOR INVESTIGATION. THE ROOT CAUSE WAS BROKEN VIAL. NO NEW TRENDS, RISKS, OR HAZARDS WERE IDENTIFIED AS A RESULT OF THE COMPLAINT. BD QUALITY WILL CONTINUE TO CLOSELY MONITOR FOR TRENDS ASSOCIATED WITH THIS FAILURE. NO NEW RISKS OR HAZARDS OR CHANGES TO EXISTING RISKS/HAZARDS WERE IDENTIFIED FOR THIS FAILURE MODE. H3 OTHER TEXT : SEE H10.

    Additional Manufacturer Narrative · 0

    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 · 0

    IT WAS REPORTED THAT WHILE USING BD BACTEC¿ FX, INSTRUMENT TOP, PACKAGED A BROKEN BOTTLE WAS OBSERVED BY THE LABORATORY PERSONNEL. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT BROKEN VIAL LEAKED IN STATION."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD BACTEC¿ FX, INSTRUMENT TOP, PACKAGED A BROKEN BOTTLE WAS OBSERVED BY THE LABORATORY PERSONNEL. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " IT WAS REPORTED THAT BROKEN VIAL LEAKED IN STATION"

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD BACTEC¿ FX, INSTRUMENT TOP, PACKAGED A BROKEN BOTTLE WAS OBSERVED BY THE LABORATORY PERSONNEL. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT BROKEN VIAL LEAKED IN STATION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    976682 BD BACTEC¿ FX, INSTRUMENT TOP, PACKAGED SYSTEM, BLOOD CULTURING MDB BECTON, DICKINSON & CO. (SPARKS) 441385 00382904413859

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown