BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 17795992 · Received September 21, 2023

    Report

    Report Number
    2647876-2023-00174
    Event Type
    Malfunction
    Date Received
    September 21, 2023
    Date of Event
    September 6, 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
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY CATALOG: 442021. BATCH NO.: 3130613. 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

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED AND/OR ADDITIONAL INFORMATION. B3: DATE OF EVENT: 06-SEP-2023. B5: DESCRIBE EVENT: REPORT 5 OF 7. IT WAS REPORTED THAT WHILE USING BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC), THERE WAS A MOLECULAR FALSE POSITIVE WITH C.TROPICALIS. NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "MOLECULAR FALSE POSITIVE WITH C.TROPICALIS. WHAT IS THE BIOFIRE (OR OTHER MANUFACTURER) LOT NUMBER? 5.1241823. WHAT ORGANISMS WERE SEEN ON GRAM STAIN? 5. PROTEUS SPP + CANDIDA TROPICALIS- (LOT NUMBER AND OCCURENCE DATE) (B)(6) AND 3130613." D4: MEDICAL DEVICE LOT#: 3130613. D4: MEDICAL DEVICE EXPIRATION DATE: 15-FEB-2024. H4: DEVICE MANUFACTURE DATE: 10-MAY-2023.

    Additional Manufacturer Narrative · 0

    D.4. MEDICAL DEVICE LOT #: UNKNOWN. D.4.MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. H.4. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 0

    REPORT 5OF 7. IT WAS REPORTED THAT WHILE USING BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC), THERE WAS A MOLECULAR FALSE POSITIVE WITH C.TROPICALIS. NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "MOLECULAR FALSE POSITIVE WITH C.TROPICALIS. WHAT IS THE BIOFIRE (OR OTHER MANUFACTURER) LOT NUMBER? 1. 0984323. WHAT ORGANISMS WERE SEEN ON GRAM STAIN? 1. CANDIDA GLABRATA + CANDIDA TROPICALIS. (LOT NUMBER & OCCURENCE DATE) AUGUST 22, 3130613.

    Description of Event or Problem · 0

    REPORT 5 OF 7. IT WAS REPORTED THAT WHILE USING BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC), THERE WAS A MOLECULAR FALSE POSITIVE WITH C.TROPICALIS. NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "MOLECULAR FALSE POSITIVE WITH C.TROPICALIS. WHAT IS THE BIOFIRE (OR OTHER MANUFACTURER) LOT NUMBER? 5.1241823. WHAT ORGANISMS WERE SEEN ON GRAM STAIN? 5. PROTEUS SPP + CANDIDA TROPICALIS- (LOT NUMBER & OCCURENCE DATE) (B)(6). 3130613".

    Description of Event or Problem · 0

    REPORT 5 OF 7. IT WAS REPORTED THAT WHILE USING BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC), THERE WAS A MOLECULAR FALSE POSITIVE WITH C.TROPICALIS. NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "MOLECULAR FALSE POSITIVE WITH C.TROPICALIS. WHAT IS THE BIOFIRE (OR OTHER MANUFACTURER) LOT NUMBER? 5.1241823. WHAT ORGANISMS WERE SEEN ON GRAM STAIN? 5. ESCHERICHIA COLI + CANDIDA TROPICALIS. WHAT ORGANISMS GREW ON CULTURE PLATE? 5. E.COLI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    510003 BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC) SYSTEM, BLOOD CULTURING MDB BECTON DICKINSON CARIBE LTD. 3130613 00382904420215

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown