BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 18009432 · Received October 26, 2023

    Report

    Report Number
    2647876-2023-00365
    Event Type
    Malfunction
    Date Received
    October 26, 2023
    Date of Event
    September 28, 2023
    Report Date
    December 29, 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
    NE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH ADDITIONAL/CORRECTED INFORMATION: D.4. MEDICAL DEVICE LOT # 2133156 H.4. DEVICE MANUFACTURE DATE: 24-MAY-2022 D.4. MEDICAL DEVICE EXPIRATION DATE: 28-FEB-2023

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: CATALOG: 442021. BATCH NO. 2133156. CUSTOMER REPORTED A MOLECULAR FALSE POSITIVE RESULT. NEITHER PHOTOS NOR RETURNED GOOD SAMPLES WERE RECEIVED. UPON FURTHER EVALUATION IT WAS NOTICED THAT COMPLAINT RECEIVED WAS FROM A PRODUCT ALREADY EXPIRED. INVESTIGATION CANNOT BE CONDUCTED TO THE RETENTION SAMPLES SINCE THE PRODUCT IS ALREADY EXPIRED. 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. THE BATCH HISTORY RECORD WAS NOT REVIEWED AS THE LOT IS EXPIRED, NONETHELESS BATCH HISTORY RECORDS ARE ALWAYS REVIEWED PRIOR TO PRODUCT RELEASE. COMPLAINT IS UNCONFIRMED.

    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

    REPORT 4 OF 7 IT WAS REPORTED THAT WHILE USING BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC), CUSTOMER HAD 7 MOLECULAR FALSE POSITIVES. CUSTOMER IS UNSURE ABOUT ANY TREATMENT CHANGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PATIENT # 4: BIOFIRE CAT # RFIT-ASY-0147, LOT # 1980823 SEQUENCE #: 446593537741 PATIENT #4: (B)(6)20/23 BACTEC SN: (B)(6) BCID2 BIOFIRE WAS A DUAL POSITIVE - STAPH SPP., C. TROPICALIS CULTURE GREW COAG NEG STAPH GRAM STAIN: GRAM POSITIVE COCCI CUSTOMER REPORTS 7 MOLECULAR FPS

    Description of Event or Problem · 0

    REPORT 4 OF 7. IT WAS REPORTED THAT WHILE USING BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC), CUSTOMER HAD 7 MOLECULAR FALSE POSITIVES. CUSTOMER IS UNSURE ABOUT ANY TREATMENT CHANGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PATIENT # 4: BIOFIRE CAT # RFIT-ASY-0147, LOT # 1980823, SEQUENCE #: (B)(6). PATIENT #4: 9/28/23. BACTEC SN: (B)(6), BCID2, BIOFIRE WAS A DUAL POSITIVE - STAPH SPP., C. TROPICALIS, CULTURE GREW COAG NEG STAPH, GRAM STAIN: GRAM POSITIVE COCCI, CUSTOMER REPORTS 7 MOLECULAR FPS.

    Description of Event or Problem · 0

    REPORT 4 OF 7. IT WAS REPORTED THAT WHILE USING BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC), CUSTOMER HAD 7 MOLECULAR FALSE POSITIVES. CUSTOMER IS UNSURE ABOUT ANY TREATMENT CHANGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PATIENT # 4: BIOFIRE CAT # RFIT-ASY-0147, LOT # 1980823 SEQUENCE #: 446593537741. PATIENT #4: (B)(6) 2023. BACTEC SN: (B)(6). BCID2. BIOFIRE WAS A DUAL POSITIVE - STAPH SPP., C. TROPICALIS. CULTURE GREW COAG NEG STAPH. GRAM STAIN: GRAM POSITIVE COCCI. CUSTOMER REPORTS 7 MOLECULAR FPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1848022 BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC) SYSTEM, BLOOD CULTURING MDB BECTON DICKINSON CARIBE LTD. 2133156 00382904420215

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown