BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BACTEC¿ FX, INSTRUMENT BOTTOM, PACKAGED

    MDR report key: 12097053 · Received June 30, 2021

    Report

    Report Number
    1119779-2021-01103
    Event Type
    Malfunction
    Date Received
    June 30, 2021
    Date of Event
    June 3, 2021
    Report Date
    December 15, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    MDB
    UDI-DI
    00382904413866
    PMA / PMN Number
    K915796
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY CUSTOMER REPORTED AN ISSUE ON A BD BACTEC FX BOTTOM INSTRUMENT (P/N 441386, S/N (B)(6) ). CUSTOMER INDICATED ABOUT THE FALSE POSITIVES. A BD FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND REPLACED THE DEFECTIVE RACK I.E., (PN# 444531 - BACTEC FX RACK ASSY SPARE) CORRESPONDING TO CASE# 01354724. CUSTOMER CONFIRMED THAT THERE ARE NO FALSE POSITIVES AFTER THE RACK REPLACEMENT IS PERFORMED. THE INSTRUMENT IS DEEMED FUNCTIONAL AND HANDED OVER TO THE CUSTOMER FOR USE. THIS IS A CONFIRMED FAILURE OF THE BD PRODUCT. DHR REVIEW IS NOT REQUIRED FOR THIS COMPLAINT AS THIS COMPLAINT DOES NOT ALLEGE AN EARLY LIFE FAILURE OR FAILURE AT INSTALLATION. 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 RACK FAILURE. NO NEW RISKS OR HAZARDS. NO NEW TRENDS AFTER TAKING THE UNCONFIRMED COMPLAINTS INTO ACCOUNT. CAPA (CORRECTIVE AND PREVENTIVE ACTION) 1233452 WAS RECENTLY IMPLEMENTED FOR FALSE POSITIVES. BD QUALITY WILL CONTINUE TO CLOSELY MONITOR FOR TRENDS ASSOCIATED WITH THIS FAILURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD BACTEC¿ FX, INSTRUMENT BOTTOM, PACKAGED 5 FALSE POSITIVE RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. A GRAM STAIN WAS USED TO CONFIRM THE RESULTS AS FALSE POSITIVES. THE CUSTOMER STATED RESULTS WERE NOT REPORTED OUT SO THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " IT WAS REPORTED THAT CUSTOMER HAD 5 FALSE POSITIVES FROM DRAWER D. CUSTOMER SENT LOG FILE AND PLOTS. "

    Additional Manufacturer Narrative · 1

    (B)(6). 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 · 1

    IT WAS REPORTED THAT WHILE USING BD BACTEC" FX, INSTRUMENT BOTTOM, PACKAGED 5 FALSE POSITIVE RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. A GRAM STAIN WAS USED TO CONFIRM THE RESULTS AS FALSE POSITIVES. THE CUSTOMER STATED RESULTS WERE NOT REPORTED OUT SO THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " IT WAS REPORTED THAT CUSTOMER HAD 5 FALSE POSITIVES FROM DRAWER D. CUSTOMER SENT LOG FILE AND PLOTS. "

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    987985 BD BACTEC¿ FX, INSTRUMENT BOTTOM, PACKAGED SYSTEM, BLOOD CULTURING MDB BECTON, DICKINSON & CO. (SPARKS) 441386 00382904413866

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown