BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 17830834 · Received September 28, 2023

    Report

    Report Number
    2647876-2023-00197
    Event Type
    Malfunction
    Date Received
    September 28, 2023
    Date of Event
    September 2, 2023
    Report Date
    October 10, 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
    ND, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: CATALOG: 442021, BATCH NO.: 3102598. 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. 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. REFER TO CUSTOMER LETTER. 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

    E.2 INITIAL REPORTER E-MAIL: (B)(6). H.3. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, 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) THAT THERE WAS MOLECULAR FALSE POSITIVES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: HAZARD, INJURY OR ERRONEOUS RESULTS? YES. HAZARD, INJURY OR ERRONEOUS RESULTS DETAILS DID ERRONEOUS RESULTS OCCUR? YES IF YES¿DETAILED ERRONEOUS RESULTS (INCLUDE # OF ERRORS AND TYPE): MOLECULAR FP FOR C. TROPICALIS. 1. WHAT RESULT DID THE CUSTOMER OBTAIN FROM THE BD PRODUCT? MOLECULAR FP FOR C. TROPICAL, E. COLI, AND KLEB PNEUMO. 2. WHAT RESULT WAS THE CUSTOMER EXPECTING TO OBTAIN (IF DIFFERENT FROM THE OBTAINED RESULT) S. AUREUS. CUSTOMER RECEIVED MOLECULAR FP FOR C. TROPICALIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC) THAT THERE WAS MOLECULAR FALSE POSITIVES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: HAZARD, INJURY OR ERRONEOUS RESULTS? YES. HAZARD, INJURY OR ERRONEOUS RESULTS DETAILS DID ERRONEOUS RESULTS OCCUR? YES. IF YES¿DETAILED ERRONEOUS RESULTS (INCLUDE # OF ERRORS AND TYPE): MOLECULAR FP FOR C. TROPICALIS. 1. WHAT RESULT DID THE CUSTOMER OBTAIN FROM THE BD PRODUCT? MOLECULAR FP FOR C. TROPICAL, E. COLI, AND KLEB PNEUMO. 2. WHAT RESULT WAS THE CUSTOMER EXPECTING TO OBTAIN (IF DIFFERENT FROM THE OBTAINED RESULT) S. AUREUS. CUSTOMER RECEIVED MOLECULAR FP FOR C. TROPICALIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    589920 BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC) SYSTEM, BLOOD CULTURING MDB BECTON DICKINSON CARIBE LTD. 3102598 00382904420215

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown