BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 17971482 · Received October 19, 2023

    Report

    Report Number
    2647876-2023-00270
    Event Type
    Malfunction
    Date Received
    October 19, 2023
    Date of Event
    September 30, 2023
    Report Date
    November 27, 2023
    Manufacturer
    BECTON DICKINSON CARIBE LTD.
    Product Code
    MDB
    UDI-DI
    00382904420239
    PMA / PMN Number
    K222591
    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: 442023. BATCH NO. 3130645. 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.

    Additional Manufacturer Narrative · 0

    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 DURING USE WITH BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) A FALSE POSITIVE RESULT FOR C. TROPICALIS WAS OBTAINED. CONFIRMATORY SUB-CULTURE WAS NEGATIVE FOR C. TROPICALIS. RESULTS WERE NOT REPORTED AND THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MOLECULAR FP FOR C. TROPICALIS. BIOFIRE PCR - ENTEROBACTERALES/E.COLI/CANDIDA TROPICALIS. CULTURE RESULTS -E.COLI.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE WITH BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) A FALSE POSTIVE RESULT FOR C. TROPICALIS WAS OBTAINED. CONFIRMATORY SUB-CULTURE WAS NEGATIVE FOR C. TROPICALIS. RESULTS WERE NOT REPORTED AND THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MOLECULAR FP FOR C. TROPICALIS. BIOFIRE PCR - ENTEROBACTERALES/E.COLI/CANDIDA TROPICALIS. CULTURE RESULTS -E.COLI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    539168 BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) SYSTEM, BLOOD CULTURING MDB BECTON DICKINSON CARIBE LTD. 3130645 00382904420239

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown