BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BACTEC¿ FX, INSTRUMENT TOP, PACKAGED

    MDR report key: 12277923 · Received August 4, 2021

    Report

    Report Number
    1119779-2021-01296
    Event Type
    Malfunction
    Date Received
    August 4, 2021
    Date of Event
    July 9, 2021
    Report Date
    March 1, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    MDB
    UDI-DI
    00382904413859
    PMA / PMN Number
    K915796
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: CUSTOMER COMPLAINT ALLEGES FALSE POSITIVES OF THEIR BACTEC FX 441385 SN: (B)(6). DRAWER A OF THEIR INSTRUMENT HAS MULTIPLE STATIONS BLOCKED. BD FIELD SERVICE ENGINEER WENT ONSITE TO INVESTIGATE THE PROBLEM AND REPLACE THE RACK. THIS IS A CONFIRMED COMPLAINT. ROOT CAUSE IS MULTIPLE DEFECTIVE STATIONS ON THE RACK, HOWEVER FURTHER DIAGNOSIS CANNOT BE DETERMINED. CAPA#410111 HAS BEEN IMPLEMENTED TO ADDRESS A FRETTING CORROSION ISSUE CAUSING RACK FAILURES. THE REPLACEMENT RACK HAS BEEN IMPLEMENTED WITH THE SOLUTION OF THE CAPA. DEVICE HISTORY REVIEW IS NOT REQUIRED AS THIS DOES NOT ALLEGE AN EARLY LIFE FAILURE, AND NO SAMPLE WAS RETURNED FOR ANALYSIS. REVIEW OF RISK MANAGEMENT FILES CONFIRMS THERE ARE NO NEW OR MODIFIED RISKS ASSOCIATED WITH THIS FAILURE MODE. BD QUALITY WILL CONTINUE TO MONITOR FOR TRENDS ASSOCIATED WITH THE FAILURE MODE DESCRIBED IN THIS COMPLAINT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD BACTEC¿ FX, INSTRUMENT TOP, PACKAGED 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 REPORTED OUT, BUT THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " IT WAS REPORTED THAT FALSE POSITIVES "

    Additional Manufacturer Narrative · 1

    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 TOP, PACKAGED 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 REPORTED OUT, BUT THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT FALSE POSITIVES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1170573 BD BACTEC¿ FX, INSTRUMENT TOP, PACKAGED SYSTEM, BLOOD CULTURING MDB BECTON, DICKINSON & CO. (SPARKS) 441385 00382904413859

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown