BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 17795375 · Received September 21, 2023

    Report

    Report Number
    2647876-2023-00172
    Event Type
    Malfunction
    Date Received
    September 21, 2023
    Date of Event
    August 24, 2023
    Report Date
    December 7, 2023
    Manufacturer
    BECTON DICKINSON CARIBE LTD.
    Product Code
    MDB
    UDI-DI
    00382904420215
    PMA / PMN Number
    K123903
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY. CATALOG: 442021. BATCH NO.: 3138058. CUSTOMER REPORTED A MOLECULAR FALSE POSITIVE RESULT. 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. 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. H3 OTHER TEXT : SEE H.10.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED AND/OR ADDITIONAL INFORMATION. B3: DATE OF EVENT: 24-AUG-2023. B5: DESCRIBE EVENT: REPORT 2 OF 7 IT WAS REPORTED THAT WHILE USING BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC), THERE WAS A MOLECULAR FALSE POSITIVE WITH C.TROPICALIS. NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "MOLECULAR FALSE POSITIVE WITH C.TROPICALIS. WHAT IS THE BIOFIRE (OR OTHER MANUFACTURER) LOT NUMBER? 2. 1556823. WHAT ORGANISMS WERE SEEN ON GRAM STAIN? 2.ENTEROCOCCUS FAECALIS + CANDIDA TROPICALIS. AUGUST 24, 3138058".

    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 7 IT WAS REPORTED THAT WHILE USING BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC), THERE WAS A MOLECULAR FALSE POSITIVE WITH C.TROPICALIS. NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "MOLECULAR FALSE POSITIVE WITH C.TROPICALIS. WHAT IS THE BIOFIRE (OR OTHER MANUFACTURER) LOT NUMBER? 1. 0984323. WHAT ORGANISMS WERE SEEN ON GRAM STAIN? 1. CANDIDA GLABRATA + CANDIDA TROPICALIS. (LOT NUMBER & OCCURENCE DATE). AUGUST 22, 3130613.

    Description of Event or Problem · 0

    REPORT 2 OF 7. IT WAS REPORTED THAT WHILE USING BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC), THERE WAS A MOLECULAR FALSE POSITIVE WITH C.TROPICALIS. NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "MOLECULAR FALSE POSITIVE WITH C.TROPICALIS. WHAT IS THE BIOFIRE (OR OTHER MANUFACTURER) LOT NUMBER? 2. 1556823. WHAT ORGANISMS WERE SEEN ON GRAM STAIN? 2.ENTEROCOCCUS FAECALIS + CANDIDA TROPICALIS. AUGUST 24, 3138058".

    Description of Event or Problem · 0

    REPORT 2 OF 7. IT WAS REPORTED THAT WHILE USING BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC), THERE WAS A MOLECULAR FALSE POSITIVE WITH C.TROPICALIS. NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "MOLECULAR FALSE POSITIVE WITH C.TROPICALIS. WHAT IS THE BIOFIRE (OR OTHER MANUFACTURER) LOT NUMBER? 2. 1556823. WHAT ORGANISMS WERE SEEN ON GRAM STAIN? 2. CANDIDA GLABRATA + CANDIDA TROPICALIS. WHAT ORGANISMS GREW ON CULTURE PLATE? 2. CANDIDA GLABRATA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    524862 BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC) SYSTEM, BLOOD CULTURING MDB BECTON DICKINSON CARIBE LTD. 3138058 00382904420215

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown