BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BACTEC FX, INSTRUMENT BOTTOM, PACKAGED

    MDR report key: 11295130 · Received February 8, 2021

    Report

    Report Number
    1119779-2021-00268
    Event Type
    Malfunction
    Date Received
    February 8, 2021
    Date of Event
    January 13, 2021
    Report Date
    May 1, 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
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: CUSTOMER REPORTED FALSE POSITIVE ISSUE ON A BD BACTEC FX BOTTOM INSTRUMENT (P/N 441386, S/N (B)(6)). NO ERRONEOUS RESULTS WERE REPORTED TO DOCTORS, AND PATIENTS WERE NOT IMPACTED. CUSTOMER INDICATED THAT THE INSTRUMENT RETURNED POSITIVES DRAWER C ROWS C AND D. THE BOTTLES WERE 3 ANAROBIC THAT HAD BEEN IN INSTRUMENT FOR AROUND 3 DAYS. A BD SYSTEM SERVICE ENGINEER (SSE) REVIEWED THE LOG FILES AND DID NOT IDENTIFIED ANY INSTRUMENTATION ISSUES. THE INCUBATION SYSTEM, AGITATION SYSTEM, AND THE TESTING MODULES WERE IN SPECIFICATION AND WERE WORKING AS INTENDED. REVIEW OF THE DEVICE HISTORY RECORD IS NOT REQUIRED DUE TO THE AGE OF THE INSTRUMENT. SERVICE HISTORY RECORD REVIEW REVEALED NO PREVIOUS COMPLAINTS FOR THIS ISSUE. BD QUALITY DID NOT RECEIVE ANY RETURNED PARTS OR INSTRUMENT FOR INVESTIGATION. THIS COMPLAINT IS AN UNCONFIRMED FAILURE OF A BD PRODUCT. THE ROOT CAUSE IS UNABLE TO BE DETERMINED. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE TESTING WITH BD BACTEC¿ FX, INSTRUMENT BOTTOM, PACKAGED 3 VIALS WERE FLAGGED POSITIVE IN DRAWERS C AND D. GRAM STAIN RESULTS WERE NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: NA. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED WHILE TESTING WITH BD BACTEC" FX, INSTRUMENT BOTTOM, PACKAGED 3 VIALS WERE FLAGGED POSITIVE IN DRAWERS C AND D. GRAM STAIN RESULTS WERE NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191562 BD BACTEC FX, INSTRUMENT BOTTOM, PACKAGED SYSTEM, BLOOD CULTURING MDB BECTON, DICKINSON & CO. (SPARKS) 441386 NA 00382904413866

    Patients

    Seq Age Sex Outcome Treatment
    1