BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 18084808 · Received November 7, 2023

    Report

    Report Number
    2647876-2023-00429
    Event Type
    Malfunction
    Date Received
    November 7, 2023
    Date of Event
    October 9, 2023
    Report Date
    December 8, 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
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY: CATALOG: 442021. BATCH NO.: 3145828 & 3151321. 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 BATCHES HAVE BEEN PREVIOUSLY INVESTIGATED FOR THE REPORTED DEFECT. COMPLAINT IS UNCONFIRMED BASED ON RETENTION SAMPLES AND BATCHES 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

    B3: DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 4 OF 4. IT WAS REPORTED THAT DURING USE WITH THE BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC), A MOLECULAR FALSE POSITIVE RESULT FOR C. TROPICALIS WAS OBTAINED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "BIOIRE PANEL: BCID2. CATALOG NUMBER: RFIT-ASY-0147. BIOFIRE LOT NUMBERS: 1288023 AND 1313023. BLANK BOTTLES OF LOT NUMBER 3151321 WAS TESTED ON THE BIOFIRE BCID2 LOT NUMBER 1313023 AND WAS POSITIVE FOR C. TROPICALIS ONLY. NO PATIENT RESULTS AFFECTED FOR BLANK BOTTLE RESULTS AFFECTED."

    Description of Event or Problem · 0

    REPORT 4 OF 4 IT WAS REPORTED THAT DURING USE WITH THE BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC), A MOLECULAR FALSE POSITIVE RESULT FOR C. TROPICALIS WAS OBTAINED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "BIOIRE PANEL: BCID2 CATALOG NUMBER: RFIT-ASY-0147 BIOFIRE LOT NUMBERS: 1288023 AND 1313023 BLANK BOTTLES OF LOT NUMBER 3151321 WAS TESTED ON THE BIOFIRE BCID2 LOT NUMBER 1313023 AND WAS POSITIVE FOR C. TROPICALIS ONLY. NO PATIENT RESULTS AFFECTED FOR BLANK BOTTLE RESULTS AFFECTED".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341830 BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC) SYSTEM, BLOOD CULTURING MDB BECTON DICKINSON CARIBE LTD. 3151321 00382904420215

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown