BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 17999810 · Received October 24, 2023

    Report

    Report Number
    3008352382-2023-00273
    Event Type
    Malfunction
    Date Received
    October 24, 2023
    Date of Event
    August 13, 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
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY CATALOG: 442021 BATCH NO.: 3109880, 3130606 & 3138057. 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 BATCH HAS BEEN PREVIOUSLY INVESTIGATED FOR THE REPORTED DEFECT. 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.

    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

    IT WAS REPORTED THAT WHILE USING BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC) MOLECULAR FALSE POSITIVE FOR C. TROPICALIS OCCURRED. CONFIRMATORY TESTING ONLY GREW STREP AGALACTIAE (GROUP B). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER STATES THEY HAVE MULTIPLE MOLECULAR FP FOR C. TROPICALIS WHAT CONFIRMATORY TESTING WAS PERFORMED THAT DETERMINED THE RESULTS WERE ERRONEOUS? SUB-CULTURE WAS NEGATIVE FOR C. TROPICALIS CULTURE RESULTS:STREP AGALACTIAE (GROUP B).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC) MOLECULAR FALSE POSITIVE FOR C. TROPICALIS OCCURRED. CONFIRMATORY TESTING ONLY GREW STREP AGALACTIAE (GROUP B) THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER STATES THEY HAVE MULTIPLE MOLECULAR FP FOR C. TROPICALIS. WHAT CONFIRMATORY TESTING WAS PERFORMED THAT DETERMINED THE RESULTS WERE ERRONEOUS? SUB-CULTURE WAS NEGATIVE FOR C. TROPICALIS. CULTURE RESULTS:STREP AGALACTIAE (GROUP B).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    688691 BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC) SYSTEM, BLOOD CULTURING MDB BECTON DICKINSON CARIBE LTD. 3109880 00382904420215

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown