BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BACTEC¿ FX, INSTRUMENT BOTTOM, PACKAGED

    MDR report key: 11747711 · Received April 29, 2021

    Report

    Report Number
    1119779-2021-00737
    Event Type
    Malfunction
    Date Received
    April 29, 2021
    Date of Event
    April 5, 2021
    Report Date
    December 2, 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
    WV, 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 POSITIVE. BD REMOTE ASSISTANCE COMMUNICATED WITH THE CUSTOMER AND CONFIRMED THAT THE RACKS WERE REPLACED IN ((B)(4)) AND THERE WERE NO FALSE POSITIVES EVER SINCE. THIS IS A CONFIRMED FAILURE OF THE BD PRODUCT. DHR/BHR REVIEW IS EXEMPT DUE TO THE COMPLAINT BEING EVALUATED VIA OTHER ELEMENTS OF THE INVESTIGATION. 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 UNABLE TO BE DETERMINED. CAPA (CORRECTIVE AND PREVENTIVE ACTION) 1233452 WAS RECENTLY IMPLEMENTED FOR FALSE POSITIVES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD BACTEC¿ FX, INSTRUMENT BOTTOM, PACKAGED A FALSE POSITIVE WAS OBTAINED BY THE LABORATORY PERSONNEL. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT FALSE POSITIVE OCCURRED. DURING A CALL TO DISCUSS FALSE POSITIVES ON THE OTHER 3 INSTRUMENTS AT THE SITE AND BD'S PLAN TO ADDRESS THEM CX SPOKE ABOUT FALSE POSITIVE ON THIS INSTRUMENT."

    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 A FALSE POSITIVE WAS OBTAINED BY THE LABORATORY PERSONNEL. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT FALSE POSITIVE OCCURRED. DURING A CALL TO DISCUSS FALSE POSITIVES ON THE OTHER 3 INSTRUMENTS AT THE SITE AND BD'S PLAN TO ADDRESS THEM CX SPOKE ABOUT FALSE POSITIVE ON THIS INSTRUMENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    641644 BD BACTEC¿ FX, INSTRUMENT BOTTOM, PACKAGED SYSTEM, BLOOD CULTURING MDB BECTON, DICKINSON & CO. (SPARKS) 441386 00382904413866

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown