BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 18006026 · Received October 25, 2023

    Report

    Report Number
    2647876-2023-00359
    Event Type
    Malfunction
    Date Received
    October 25, 2023
    Date of Event
    September 11, 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 # 2129123. D.4 MEDICAL DEVICE EXPIRATION DATE : 28-FEB-2023. H.4 DEVICE MANUFACTURE DATE: 20-MAY-2022.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: CATALOG: 442021, BATCH NO. 2129123. 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 2 OF 7. IT WAS REPORTED THAT WHILE USING BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC), CUSTOMER HAD 7 MOLECULAR FALSE POSITIVES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BIOFIRE RESULT: STAPH EPI AND C. TROPICALIS. BIOFIRE CAT # RFIT-ASY-0147, LOT # 1211323. SEQUENCE #: 446593007933 9/11/23. BACTEC SN: T10877 BCID2. BIOFIRE RESULTS WAS A DUAL POSITIVE. STAPH EPI GREW IN CULTURE. GRAM STAIN: GRAM POSITIVE COCCI. CUSTOMER REPORTS 7 MOLECULAR FPS.

    Description of Event or Problem · 0

    REPORT 2 OF 7: IT WAS REPORTED THAT WHILE USING BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC), CUSTOMER HAD 7 MOLECULAR FALSE POSITIVES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BIOFIRE RESULT: STAPH EPI AND C. TROPICALIS, BIOFIRE CAT # RFIT-ASY-0147, LOT # 1211323, SEQUENCE #: 446593007933, 9/11/2023. BACTEC SN: (B)(6). BCID2. BIOFIRE RESULTS WAS A DUAL POSITIVE. STAPH EPI GREW IN CULTURE. GRAM STAIN: GRAM POSITIVE COCCI. CUSTOMER REPORTS 7 MOLECULAR FPS.

    Description of Event or Problem · 0

    REPORT 2 OF 7 IT WAS REPORTED THAT WHILE USING BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC), CUSTOMER HAD 7 MOLECULAR FALSE POSITIVES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BIOFIRE RESULT: STAPH EPI AND C. TROPICALIS BIOFIRE CAT # RFIT-ASY-0147, LOT # 1211323 SEQUENCE #: (B)(6). 9/11/23 BACTEC SN: (B)(6). BCID2. BIOFIRE RESULTS WAS A DUAL POSITIVE. STAPH EPI GREW IN CULTURE. GRAM STAIN: GRAM POSITIVE COCCI. CUSTOMER REPORTS 7 MOLECULAR FPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1150788 BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC) SYSTEM, BLOOD CULTURING MDB BECTON DICKINSON CARIBE LTD. 2129123 00382904420215

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown