BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 18060834 · Received November 2, 2023

    Report

    Report Number
    2647876-2023-00409
    Event Type
    Malfunction
    Date Received
    November 2, 2023
    Date of Event
    October 19, 2023
    Report Date
    December 7, 2023
    Manufacturer
    BECTON DICKINSON CARIBE LTD.
    Product Code
    MDB
    UDI-DI
    00382904420239
    PMA / PMN Number
    K113558
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 BATCH HAS BEEN PREVIOUSLY INVESTIGATED FOR THE REPORTED DEFECT. COMPLAINT IS UNCONFIRMED BASED ON RETENTION SAMPLES AND BATCH HISTORY RECORD REVIEW RESULTS.

    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¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC), THERE WERE 45 MOLECULAR FALSE POSITIVE RESULTS. NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER STATES SHE IS UNABLE TO GIVE A NUMBER OF BOTTLES THAT WERE AFFECTED AS A TOTAL OF 45 BOTTLES EXHIBITED MOLECULAR FP FOR C. TROPICALIS AND ALL HAVE BEEN DISCARDED. BIOFIRE PANEL TYPE (BCID1 OR 2): BCDI2. BIOFIRE CATALOG: UNKNOWN . BIOFIRE LOT NUMBER: 2YZE23 AND 2WPD23. WAS BIOFIRE RESULT DUAL POSITIVE? YES. WHAT ORGANISMS GREW? UNKNOWN AS CUSTOMER DOES NOT HAVE INFORMATION AVAILABLE ON THE INDIVIDUAL BOTTLES . WHAT WAS SEEN IN THE GRAM STAIN? THE YEAST WAS NEVER SEEN ON GRAM STAIN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC), THERE WERE 45 MOLECULAR FALSE POSITIVE RESULTS. NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER STATES SHE IS UNABLE TO GIVE A NUMBER OF BOTTLES THAT WERE AFFECTED AS A TOTAL OF 45 BOTTLES EXHIBITED MOLECULAR FP FOR C. TROPICALIS AND ALL HAVE BEEN DISCARDED. BIOFIRE PANEL TYPE (BCID1 OR 2): BCDI2. BIOFIRE CATALOG: UNKNOWN . BIOFIRE LOT NUMBER: 2YZE23 AND 2WPD23. WAS BIOFIRE RESULT DUAL POSITIVE? YES. WHAT ORGANISMS GREW? UNKNOWN AS CUSTOMER DOES NOT HAVE INFORMATION AVAILABLE ON THE INDIVIDUAL BOTTLES. · WHAT WAS SEEN IN THE GRAM STAIN? THE YEAST WAS NEVER SEEN ON GRAM STAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341532 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