BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BACTEC PLUS AEROBIC/F CULTURE VIALS (PLASTIC)

    MDR report key: 12569628 · Received October 4, 2021

    Report

    Report Number
    2647876-2021-00142
    Event Type
    Malfunction
    Date Received
    October 4, 2021
    Date of Event
    September 7, 2021
    Report Date
    September 9, 2021
    Manufacturer
    BECTON DICKINSON CARIBE LTD.
    Product Code
    MDB
    UDI-DI
    00382904420239
    PMA / PMN Number
    K113558
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: CUSTOMER REPORTED A POSITIVE ID RESULT FOR BACTEC MEDIA, WHILE USING BIOFIRE FILMARRAY® BLOOD CULTURE IDENTIFICATION BDIC/BCID2 PANELS. BD WAS UNABLE TO REPRODUCE THE CUSTOMER¿S EXPERIENCE WITH THE BACTEC PRODUCT BASED ON OUR INTERNAL PROCEDURES AND THE INTENDED USE OF THE PRODUCT. RETENTION SAMPLES WERE VISUALLY INSPECTED, TESTED FOR VIABLE CONTAMINATION BY SUB-CULTURING ON TSA, CHOCOLATE, SABOURAUD AND SCHAEDLER AGARS PLATES, VOLTAGE OUTPUT AND GRAM STAIN. ALL RESULTS WERE SATISFACTORY. BATCH HISTORY RECORD REVIEW DID NOT IDENTIFY ANY EVIDENCE FOR WHICH THE CUSTOMER SUBMITTED THE COMPLAINT. A COMPLAINT HISTORY REVIEW WAS CONDUCTED BATCH HAS BEEN PREVIOUSLY INVESTIGATED FOR THE REPORTED DEFECT. CATALOG 442023 BATCH NO. 1160559. COMPLAINT IS UNCONFIRMED BASED ON RETENTION SAMPLES AND BATCH HISTORY RECORD REVIEW RESULTS. AS PER PRODUCT INSERT A GRAM-STAINED SMEAR FROM CULTURE MEDIUM MAY CONTAIN SMALL NUMBERS OF NONVIABLE ORGANISMS DERIVED FROM MEDIA CONSTITUENTS, STAINING REAGENTS, IMMERSION OIL, GLASS SLIDES, AND SPECIMENS USED FOR INOCULATION. DUE TO THE NATURE OF BIOLOGICAL MATERIALS IN MEDIA PRODUCTS AND INHERENT ORGANISM VARIABILITY, THE USER SHOULD BE COGNIZANT OF POTENTIAL VARIABLE RESULTS IN THE RECOVERY OF CERTAIN MICROORGANISMS. MOLECULAR TESTS PERFORMED ON POSITIVE BLOOD CULTURES WILL DETECT BOTH VIABLE AND NON-VIABLE ORGANISMS COMMONLY FOUND IN CULTURE MEDIA. THEREFORE, MOLECULAR TEST RESULTS SHOULD BE EVALUATED IN CONJUNCTION WITH GRAM STAIN RESULTS IN ACCORDANCE WITH STANDARD-OF-CARE PRACTICES AS WELL AS MANUFACTURER¿S INSTRUCTIONS FOR USE. NO CORRECTIVE ACTIONS WERE REQUIRED. A CROSS FUNCTIONAL TEAM CONTINUALLY MONITORS ALL PRODUCT COMPLAINTS FOR TRENDS AND DETERMINES IF ANY ADDITIONAL ACTIONS ARE NECESSARY BEYOND THE CURRENT INVESTIGATIONAL PROCESS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT POSSIBLE CONTAMINATION OF 2 BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) CAUSED THEM TO PRODUCE FALSE POSITIVE RESULTS FOR ACINETOBACTER BAUMANII. LAB PERSONNEL WERE UNABLE TO GROW THIS IN CULTURES FOR CONFIRMATORY TESTING, AND ERRONEOUS RESULTS WERE NOT REPORTED TO CLINICIANS. THERE WAS ALSO NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER REPORTING POSSIBLE CONTAMINATION WITH ACINETOBACTER IN THEIR BACTEC BOTTLES - AEROBIC BOTTLE, LOT#1160559 - ANAEROBIC BOTTLE, LOT#1167757." 'CUSTOMER STATES THEY HAVE HAD TWO BOTTLES COME POSITIVE FROM THE BACTEC WITH TWO ORGANISMS. ONE OF THE ORGANISMS IS ACINETOBACTER BAUMANII WHICH THEY HAVE NOT BEEN ABLE TO GROW IN CULTURE." "WAS THE ACINETOBACTER BAUMANII REPORTED OUT FOR THIS PATIENT? NO".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1471079 BD BACTEC PLUS AEROBIC/F CULTURE VIALS (PLASTIC) BLOOD CULTURING SYSTEM MDB BECTON DICKINSON CARIBE LTD. 442023 1160559 00382904420239

    Patients

    Seq Age Sex Outcome Treatment
    1