BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BACTEC¿ FX, INSTRUMENT TOP, PACKAGED

    MDR report key: 11844791 · Received May 18, 2021

    Report

    Report Number
    1119779-2021-00851
    Event Type
    Malfunction
    Date Received
    May 18, 2021
    Date of Event
    April 28, 2021
    Report Date
    November 18, 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
    AU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: A DECONTAMINATION ISSUE WAS REPORTED FOR DRAWER ISSUE IN DRAWER B ON A BD BACTEC FX TOP INSTRUMENT (P/N 441385, S/N (B)(6) ) . AN FSE WAS DISPATCHED AND FOUND THE BOTTLE WAS WRONGLY INSERTED DUE TO WHICH THE BOTTLE IS BROKEN. SO THE DRAWER B RACKS UNITS WERE REMOVED AND CLEANED, THE CIRCUIT BOARDS OF THE DRAWER AND ELECTRONICS DRAWER CHECKED FOR LIQUID AND LIQUID INGRESS AND TRACES ON THE ELECTRONIC COMPONENTS. AFTER CLEANING RAN THE DEVICE ON A TEST BASIS AFTER WHICH DRAWER B AND THE INSTRUMENT HAD NO ISSUES AND THE SYSTEM WAS RELEASED TO CUSTOMER FOR USE . 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 ONE PREVIOUS COMPLAINT FOR CONTAMINATION ISSUES (1800932) . BD QUALITY DID NOT RECEIVE ANY RETURNED INSTRUMENT OR PARTS FOR INVESTIGATION. THIS COMPLAINT IS A CONFIRMED FAILURE OF A BD PRODUCT. THE ROOT CAUSE WAS DUE TO DEFECTIVE BROKEN BOTTLES. BD QUALITY WILL CONTINUE TO CLOSELY MONITOR FOR TRENDS ASSOCIATED WITH THIS FAILURE.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD BACTEC¿ FX, INSTRUMENT TOP, PACKAGED THE BOTTLE WAS INSERTED INCORRECTLY AND THE BOTTLE WAS BROKEN. THERE WAS NO REPORT OF USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM GERMAN TO ENGLISH: WRONGLY INSERTED BOTTLE WHICH IS BROKEN CUSTOMER REPORTS THE ABOVE AND ASKS FOR ASSISTANCE WITH THE DECONTAMINATION ADDITIONALLY, THE FSE PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: DRAWER B RACKS UNITS REMOVED AND CLEANED, THE CIRCUIT BOARDS OF THE DRAWER AND ELECTRONICS DRAWER CHECKED FOR LIQUID, LIQUID INGRESS AND TRACES ON THE ELECTRONIC COMPONENTS ARE NOT VISIBLE, CONSEQUENTIAL ERRORS CANNOT BE RULED OUT, RUN THE DEVICE ON A TEST BASIS AFTER WHICH DRAWER B CAN BE USED AGAIN.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: NA. INITIAL REPORTER PHONE NUMBER: (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED WHILE USING BD BACTEC¿ FX, INSTRUMENT TOP, PACKAGED THE BOTTLE WAS INSERTED INCORRECTLY AND THE BOTTLE WAS BROKEN. THERE WAS NO REPORT OF USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: WRONGLY INSERTED BOTTLE WHICH IS BROKEN. CUSTOMER REPORTS THE ABOVE AND ASKS FOR ASSISTANCE WITH THE DECONTAMINATION. ADDITIONALLY, THE FSE PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: DRAWER B RACKS UNITS REMOVED AND CLEANED, THE CIRCUIT BOARDS OF THE DRAWER AND ELECTRONICS DRAWER CHECKED FOR LIQUID, LIQUID INGRESS AND TRACES ON THE ELECTRONIC COMPONENTS ARE NOT VISIBLE, CONSEQUENTIAL ERRORS CANNOT BE RULED OUT, RUN THE DEVICE ON A TEST BASIS AFTER WHICH DRAWER B CAN BE USED AGAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738775 BD BACTEC¿ FX, INSTRUMENT TOP, PACKAGED SYSTEM, BLOOD CULTURING MDB BECTON, DICKINSON & CO. (SPARKS) 441385 NA 00382904413859

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown