BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 23543199 · Received November 13, 2025

    Report

    Report Number
    2647876-2025-00709
    Event Type
    Malfunction
    Date Received
    November 13, 2025
    Date of Event
    October 27, 2025
    Report Date
    December 8, 2025
    Manufacturer
    BECTON DICKINSON CARIBE LTD.
    Product Code
    MDB
    UDI-DI
    30382904420223
    PMA / PMN Number
    K141810
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: CATALOG 442022. BATCH NO. 5121637. CUSTOMER REPORTED A FALSE NEGATIVE RESULT. NEITHER PHOTOS NOR RETURNED GOOD SAMPLES WERE RECEIVED. BD WAS UNABLE TO REPRODUCE CUSTOMER¿S EXPERIENCE WITH BACTEC PRODUCT. SATISFACTORY RESULTS WERE OBTAINED FROM RETENTION SAMPLES WHEN TESTED FOR MICROBIAL INSTRUMENT DETECTION AS PER QUALITY PROCEDURES. BATCH HISTORY RECORD REVIEW DID NOT IDENTIFY ANY EVIDENCE FOR WHICH THE CUSTOMER SUBMITTED THE COMPLAINT (I.E. FALSE NEGATIVE). MICROBIAL INSTRUMENT DETECTION INDICATED THAT THE PRODUCT IS PERFORMING AS EXPECTED. 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. COMPLAINT IS UNCONFIRMED BASED ON RETENTION SAMPLES AND BATCH RECORD REVIEW RESULTS. PRODUCT INSERT WARNINGS AND PRECAUTIONS SECTIONS STATES THAT PRIOR TO USE, EACH VIAL SHOULD BE EXAMINED FOR EVIDENCE OF CONTAMINATION SUCH AS CLOUDINESS, BULGING OR DEPRESSES SEPTUM, OR LEAKAGE. VIALS SHOWING EVIDENCE OF CONTAMINATION SHOULD NOT BE USED. ALSO PRIOR TO USE, THE USER SHOULD EXAMINE THE VIAL FOR EVIDENCE OF DAMAGE OR DETERIORATION. VIALS DISPLAYING TURBIDITY, CONTAMINATION, OR DISCOLORATION (DARKENING) SHOULD NOT BE USED. THE SPECIMEN MUST BE COLLECTED USING STERILE TECHNIQUES TO REDUCE THE CHANCE OF CONTAMINATION. 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

    E.1: INITIAL REPORTER ADDR 1: (B)(6). 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

    IT WAS REPORTED WHILE USING BD BACTEC¿ PLUS ANAEROBIC/F CULTURE VIALS (PLASTIC) THERE WAS ONE FALSE NEGATIVE RESULT. THE MATRIX WAS NOT BLOOD. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER. THIS IS REPORT 46 OF 90.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD BACTEC¿ PLUS ANAEROBIC/F CULTURE VIALS (PLASTIC) THERE WAS ONE FALSE NEGATIVE RESULT. THE MATRIX WAS NOT BLOOD. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER. THIS IS REPORT 46 OF 90.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2248852 BD BACTEC¿ PLUS ANAEROBIC/F CULTURE VIALS (PLASTIC) SYSTEM, BLOOD CULTURING MDB BECTON DICKINSON CARIBE LTD. 5121637 30382904420223

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown