BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC)

    MDR report key: 17981495 · Received October 20, 2023

    Report

    Report Number
    2647876-2023-00319
    Event Type
    Malfunction
    Date Received
    October 20, 2023
    Date of Event
    September 28, 2023
    Report Date
    July 12, 2024
    Manufacturer
    BECTON DICKINSON CARIBE LTD.
    Product Code
    MDB
    UDI-DI
    00382904420215
    PMA / PMN Number
    K123903
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH ADDITIONAL INFORMATION. D9: DEVICE AVAILABLE FOR EVALUATION: YES. D9: RETURNED TO MANUFACTURER ON: 17-NOV-2023. INVESTIGATION SUMMARY: CATALOG: 442021. BATCH NO.: 3130610. CUSTOMER REPORTED A MOLECULAR FALSE POSITIVE RESULT. 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/RETURNED 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 BATCH HAS BEEN PREVIOUSLY INVESTIGATED FOR THE REPORTED DEFECT. COMPLAINT IS UNCONFIRMED BASED ON RETENTION/RETURNED 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.

    Additional Manufacturer Narrative · 0

    H.3. 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 · 0

    REPORT 2 OF 2. IT WAS REPORTED THAT WHILE USING BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC), THERE WERE AN UNSPECIFIED NUMBER OF MOLECULAR FALSE POSITIVE RESULTS FOR C. TROPICALIS. NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER IS REPORTING POSITIVE C. TROPICALIS FROM BIOFIRE BUT NO YEAST SEEN ON THE GRAM STAIN AND NO YEAST GREW IN CULTURE. WHAT RESULT DID THE CUSTOMER OBTAIN FROM THE BD PRODUCT? BIOFIRE POSITIVE FOR C. TROPICALIS. BIOFIRE PANEL TYPE (BCID1 OR 2): BCID2. -BIOFIRE CATALOG#: UNABLE TO PROVIDE, CUSTOMER DOES NOT HAVE THE BOX. -BIOFIRE LOT NUMBER:2UXP23 IS LOT NUMBER FOUND ON INSTRUMENT PRINT OUT. -WAS BIOFIRE RESULT DUAL POSITIVE? CUSTOMER STATES THAT THE BIOFIRE RESULT IS ALWAYS A DUAL POSITIVE. ¿ WHAT ORGANISMS GREW? NO YEAST GROWTH ON CULTURE. ¿ WHAT WAS SEEN IN THE GRAM STAIN? NO YEAST SEEN ON GRAM STAIN. -PLEASE PROVIDE YOUR BACTEC FX SERIAL NUMBER: (B)(6). -HOW MANY BOTTLES WERE FROM 3109871 AND HOW MANY WERE FROM 3130610. CUSTOMER STATES ABOUT 4-5 PATIENTS FOR LOT NUMBER 3109871. CUSTOMER UNABLE TO PROVIDE AN APPROXIMATE NUMBER OF PATIENTS FOR LOT 3130610".

    Description of Event or Problem · 0

    REPORT 2 OF 2. IT WAS REPORTED THAT WHILE USING BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC), THERE WERE AN UNSPECIFIED NUMBER OF MOLECULAR FALSE POSITIVE RESULTS FOR C. TROPICALIS. NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER IS REPORTING POSITIVE C. TROPICALIS FROM BIOFIRE BUT NO YEAST SEEN ON THE GRAM STAIN AND NO YEAST GREW IN CULTURE. WHAT RESULT DID THE CUSTOMER OBTAIN FROM THE BD PRODUCT? BIOFIRE POSITIVE FOR C. TROPICALIS BIOFIRE PANEL TYPE (BCID1 OR 2): BCID2 -BIOFIRE CATALOG#: UNABLE TO PROVIDE, CUSTOMER DOES NOT HAVE THE BOX -BIOFIRE LOT NUMBER:2UXP23 IS LOT NUMBER FOUND ON INSTRUMENT PRINT OUT -WAS BIOFIRE RESULT DUAL POSITIVE? CUSTOMER STATES THAT THE BIOFIRE RESULT IS ALWAYS A DUAL POSITIVE ¿ WHAT ORGANISMS GREW?: NO YEAST GROWTH ON CULTURE. ¿ WHAT WAS SEEN IN THE GRAM STAIN?: NO YEAST SEEN ON GRAM STAIN. -PLEASE PROVIDE YOUR BACTEC FX SERIAL NUMBER: (B)(6). -HOW MANY BOTTLES WERE FROM 3109871 AND HOW MANY WERE FROM 3130610?: CUSTOMER STATES ABOUT 4-5 PATIENTS FOR LOT NUMBER 3109871. CUSTOMER UNABLE TO PROVIDE AN APPROXIMATE NUMBER OF PATIENTS FOR LOT 3130610".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1995973 BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC) SYSTEM, BLOOD CULTURING MDB BECTON DICKINSON CARIBE LTD. 3130610 00382904420215

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown