BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BACTEC¿ FX, INSTRUMENT BOTTOM, PACKAGED

    MDR report key: 12271346 · Received August 3, 2021

    Report

    Report Number
    1119779-2021-01279
    Event Type
    Malfunction
    Date Received
    August 3, 2021
    Date of Event
    July 8, 2021
    Report Date
    March 25, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    MDB
    UDI-DI
    00382904413866
    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

    H6: INVESTIGATION SUMMARY: A COMPLAINT OF "TWO STATIONS REPORTING UNUSABLE DUE TO BROKEN BOTTLES IN DRAWER D" WAS RECEIVED AGAINST INSTRUMENT BOTTOM BACTEC FX PACKAGED MATERIAL NUMBER: 441386, SERIAL NUMBER: (B)(6). A BD REMOTE ASSISTANCE ASSOCIATE COMMUNICATED WITH THE CUSTOMER AND INSTRUCTED TO BLOCK THE STATIONS AND ADVISED TO DO DECONTAMINATION AND CLEAN UP WITH RECOMMENDED SOLUTION, THUS THE ISSUE WAS RESOLVED. THIS COMPLAINT IS AN UNCONFIRMED FAILURE OF THE BD PRODUCT, AND THE ROOT CAUSE WAS UNABLE TO BE DETERMINED BASED ON THE PROVIDED INFORMATION. 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 REVIEW REVEALED NO PREVIOUS COMPLAINTS FOR THIS ISSUE. NO PARTS WERE REPLACED AS PART OF THIS COMPLAINT, AND THEREFORE NO SAMPLES WERE RETURNED, AND NO RETURNED MATERIAL INVESTIGATION COULD OCCUR. 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 COMPLAINT. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD BACTEC¿ FX, INSTRUMENT BOTTOM, PACKAGED BROKEN BOTTLES WERE OBSERVED BY THE LABORATORY PERSONNEL. THERE WAS NO IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " CALL ACTIVITY COMMENT: ¿ CUSTOMER PROBLEM: CUSTOMER CALLED TO REPORT DRAWER D HAS TWO STATIONS REPORTING UNUSABLE DUE TO A BROKEN BOTTLE. "

    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 BOTTOM, PACKAGED BROKEN BOTTLES WERE OBSERVED BY THE LABORATORY PERSONNEL. THERE WAS NO IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " CALL ACTIVITY COMMENT: CUSTOMER PROBLEM: CUSTOMER CALLED TO REPORT DRAWER D HAS TWO STATIONS REPORTING UNUSABLE DUE TO A BROKEN BOTTLE. ".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1164566 BD BACTEC¿ FX, INSTRUMENT BOTTOM, PACKAGED SYSTEM, BLOOD CULTURING MDB BECTON, DICKINSON & CO. (SPARKS) 441386 00382904413866

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown