BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 18016397 · Received October 26, 2023

    Report

    Report Number
    2647876-2023-00375
    Event Type
    Malfunction
    Date Received
    October 26, 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.H.6 INVESTIGATION SUMMARY.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED AND/OR ADDITIONAL INFORMATION. B5: DESCRIBE EVENT OR PROBLEM: REPORT 1 OF 4. IT WAS REPORTED THAT WHIIE USING BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC), THERE WAS A MOLECULAR FALSE POSITIVE OF CANDIDA TROPICALIS. NO PATIENT IMPACT OR TREATMENT CHANGE REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER REPORTS ISSUES WITH BOTTLES HAVING NON-VIABLE CANDIDA TROPICALIS SHOWING UP ON BLOOD CULTURE ID PANEL ON BIOFIRE. LOT NUMBERS 3145828, 3151321. PATIENT 3 LOT 3151321. RESULT WAS DUAL POSITIVE. CULTURE RESULT: STAPHYLOCOCCUS HOMINIS. GRAM STAIN MATCHED CULTURE. RESULT REPORTED BUT UNKNOWN IF TREATMENT WAS CHANGED." B6: RELEVANT TESTS/LAB DATA: CULTURE AND GRAM STAIN. D4: MEDICAL DEVICE LOT#: 3151321. D4: MEDICAL DEVICE EXPIRATION DATE: 01-MAR-2024. H4: DEVICE MANUFACTURE DATE: 31-MAY-2023.

    Additional Manufacturer Narrative · 0

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH ADDITIONAL LOT NUMBER IS AS FOLLOWS: D4. MEDICAL DEVICE LOT#: 3151321, D4. MEDICAL DEVICE EXPIRATION DATE: 01-03-2024, H4. DEVICE MANUFACTURE DATE: 31-05-2023. 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 1 OF 4. IT WAS REPORTED THAT WHIIE USING BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC), THERE WAS A MOLECULAR FALSE POSITIVE OF CANDIDA TROPICALIS. NO PATIENT IMPACT OR TREATMENT CHANGE REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER REPORTS ISSUES WITH BOTTLES HAVING NON-VIABLE CANDIDA TROPICALIS SHOWING UP ON BLOOD CULTURE ID PANEL ON BIOFIRE LOT NUMBERS 3145828, 3151321. PATIENT 3 LOT 3151321 . RESULT WAS DUAL POSITIVE. HOMINIS. GRAM STAIN MATCHED CULTURE. RESULT REPORTED BUT UNKNOWN IF TREATMENT WAS CHANGED."

    Description of Event or Problem · 0

    REPORT 1 OF 4. IT WAS REPORTED THAT WHILE USING BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC), THERE WAS A MOLECULAR FALSE POSITIVE OF CANDIDA TROPICALIS. NO PATIENT IMPACT OR TREATMENT CHANGE REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER REPORTS ISSUES WITH BOTTLES HAVING NON-VIABLE CANDIDA TROPICALIS SHOWING UP ON BLOOD CULTURE ID PANEL ON BIOFIRE. LOT NUMBERS 3145828, 3151321. PATIENT 3 LOT 3151321 RESULT WAS DUAL POSITIVE CULTURE RESULT: STAPHYLOCOCCUS HOMINIS GRAM STAIN MATCHED CULTURE RESULT REPORTED BUT UNKNOWN IF TREATMENT WAS CHANGED."

    Description of Event or Problem · 0

    REPORT 1 OF 2. IT WAS REPORTED THAT WHIIE USING BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC), THERE WAS A MOLECULAR FALSE POSITIVE OF CANDIDA TROPICALIS. NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER REPORTS ISSUES WITH BOTTLES HAVING NON-VIABLE CANDIDA TROPICALIS SHOWING UP ON BLOOD CULTURE ID PANEL ON BIOFIRE LOT NUMBERS 3145828, 3151321."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1048066 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