BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC)

    MDR report key: 17102254 · Received June 10, 2023

    Report

    Report Number
    3008352382-2023-00099
    Event Type
    Malfunction
    Date Received
    June 10, 2023
    Date of Event
    January 16, 2023
    Report Date
    August 14, 2025
    Manufacturer
    BECTON DICKINSON CARIBE LTD.
    Product Code
    MDB
    UDI-DI
    00382904420239
    PMA / PMN Number
    K113558
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WAS MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH ADDITIONAL LOT NUMBER IS AS FOLLOWS: D4. MEDICAL DEVICE LOT#: 3013790 D4. MEDICAL DEVICE EXPIRATION DATE: 19-OCT-2023 H4. DEVICE MANUFACTURE DATE: 13-JAN-2023.

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY: CUSTOMER REPORTED A POSITIVE ID RESULT FOR BACTEC MEDIA, WHILE USING BIOFIRE FILMARRAY® BLOOD CULTURE IDENTIFICATION. NEITHER PHOTOS NOR RETURNED GOOD SAMPLES WERE RECEIVED. 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 AND ONLY THE CURRENT COMPLAINT WAS FOUND RELATING TO THE INCIDENT LOT NUMBER AND THE ¿AS REPORTED¿ DEFECT CODE. 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.

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING UPDATES HAVE BEEN MADE: THIS MDR PERTAINS ONLY TO LOT NUMBER 3011327. B5. IT WAS REPORTED WHILE USING BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC), THERE WAS A MOLECULAR FALSE POSITIVE RESULT. THERE WAS NO REPORT OF PATIENT IMPACT. THIS SUPPLEMENTAL MDR IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW OF RECORDS DATING APRIL 2023¿2025, UNDER CAPA 11910483.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) MOLECULAR FALSE POSITIVES ARE BEING REPORTED OF CANDIDA TROPICALIS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MOLECULAR FALSE POSITIVE - CANDIDA TROPICALIS. CUSTOMER REPORTS SEVERAL MOLECULAR FP. THE BOTTLES WOULD FLAG AS POSITIVE AND A BIOFIRE TEST WOULD BE DONE. BIOFIRE GAVE POSITIVE FOR CANDIDA TROPICALIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) MOLECULAR FALSE POSITIVES ARE BEING REPORTED OF CANDIDA TROPICALIS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER:MOLECULAR FALSE POSITIVE - CANDIDA TROPICALIS.CUSTOMER REPORTS SEVERAL MOLECULAR FP. THE BOTTLES WOULD FLAG AS POSITIVE AND A BIOFIRE TEST WOULD BE DONE. BIOFIRE GAVE POSITIVE FOR CANDIDA TROPICALIS

    Description of Event or Problem · 0

    REPORT 1 OF 3. IT WAS REPORTED THAT BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) MOLECULAR FALSE POSITIVES ARE BEING REPORTED OF CANDIDA TROPICALIS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MOLECULAR FALSE POSITIVE - CANDIDA TROPICALIS.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC), THERE WAS A MOLECULAR FALSE POSITIVE RESULT. THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2270953 BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) SYSTEM, BLOOD CULTURING MDB BECTON DICKINSON CARIBE LTD. 442023 SEE H.10 00382904420239

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown