BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BACTEC¿ PEDS PLUS¿/ F CULTURE VIALS (PLASTIC)

    MDR report key: 18622510 · Received February 1, 2024

    Report

    Report Number
    2647876-2024-00020
    Event Type
    Malfunction
    Date Received
    February 1, 2024
    Date of Event
    December 20, 2023
    Report Date
    February 14, 2024
    Manufacturer
    BECTON DICKINSON CARIBE LTD.
    Product Code
    MDB
    UDI-DI
    00382904420208
    PMA / PMN Number
    K151866
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY CATALOG 442020 BATCH NO. 3110967 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. 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. H3 OTHER TEXT : SEE H.10

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    REPORT 1 OF 3. IT WAS REPORTED THAT WHILE USING THE BD BACTEC¿ PEDS PLUS¿/ F CULTURE VIALS (PLASTIC) THATB CANDIDA TROPICALIS IS DETECTED IN SEPSIS PANEL (PANEL BOTTLE LOT: 3110967, PANEL BOTTLE EXPIRATION DATE: 01/24/2024, BIOFIRE BCID2 PANEL LOT: 318023) FOLLOWING THE PROTOCOL, THE BLOOD CULTURE GRAM IS REVIEWED DONE BY MICROBIOLOGY AND THE GRAM DONE BY MOLECULAR BIOLOGY, IN NEITHER OF THEM ARE YEASTS OR BLASTOCONIDIA OBSERVED, THEREFORE THE EXAMINATION IS VALIDATED WITHOUT THE DETECTION OF C. TROPICALIS. NO PATIENT IMPACT REPORTED.

    Description of Event or Problem · 0

    REPORT 1 OF 3. IT WAS REPORTED THAT WHILE USING THE BD BACTEC¿ PEDS PLUS¿/ F CULTURE VIALS (PLASTIC) THATB CANDIDA TROPICALIS IS DETECTED IN SEPSIS PANEL (PANEL BOTTLE LOT: 3110967, PANEL BOTTLE EXPIRATION DATE: 01/24/2024, BIOFIRE BCID2 PANEL LOT: 318023) FOLLOWING THE PROTOCOL, THE BLOOD CULTURE GRAM IS REVIEWED DONE BY MICROBIOLOGY AND THE GRAM DONE BY MOLECULAR BIOLOGY, IN NEITHER OF THEM ARE YEASTS OR BLASTOCONIDIA OBSERVED, THEREFORE THE EXAMINATION IS VALIDATED WITHOUT THE DETECTION OF C. TROPICALIS. NO PATIENT IMPACT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385832 BD BACTEC¿ PEDS PLUS¿/ F CULTURE VIALS (PLASTIC) SYSTEM, BLOOD CULTURING MDB BECTON DICKINSON CARIBE LTD. 3110967 00382904420208

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown