BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 23533305 · Received November 12, 2025

    Report

    Report Number
    2647876-2025-00664
    Event Type
    Malfunction
    Date Received
    November 12, 2025
    Date of Event
    November 5, 2025
    Report Date
    December 3, 2025
    Manufacturer
    BECTON DICKINSON CARIBE LTD.
    Product Code
    MDB
    UDI-DI
    00382904420239
    PMA / PMN Number
    K113558
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: CATALOG 442023. BATCH NO. 5093585. CUSTOMER REPORTED A LEAKAGE ISSUE. PHOTO OF AN INOCULATED BOTTLE WITH A LEAKAGE ISSUE WAS RECEIVED. BD WAS UNABLE TO REPRODUCE CUSTOMER¿S EXPERIENCE WITH THE BACTEC PRODUCT FOR LEAKAGE DEFECT. SATISFACTORY RESULTS WERE OBTAINED FROM RETENTION SAMPLES WHEN VISUALLY INSPECTED. VACUUM DRAW WAS PERFORMED WITH SATISFACTORY RESULTS. IN ADDITION, FIVE (5) SAMPLES WERE RANDOMLY SELECTED, AND INSPECTED FOR ANY DAMAGE AND NO ISSUES WERE OBSERVED. BATCH HISTORY RECORD REVIEW DID NOT IDENTIFY ANY EVIDENCE FOR WHICH THE CUSTOMER SUBMITTED THE COMPLAINT. 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 CONFIRMED BASED PHOTOS RECEIVED. PRODUCT INSERT STATES PRIOR TO USE; THE USER SHOULD EXAMINE THE VIALS FOR EVIDENCE OF DAMAGE OR DETERIORATION. VIALS DISPLAYING TURBIDITY, CONTAMINATION, OR DISCOLORATION (DARKENING) SHOULD NOT BE USED. ON RARE OCCASIONS, A VIAL MAY NOT BE SEALED SUFFICIENTLY. THE CONTENTS OF THE VIALS MAY LEAK OR SPILL, ESPECIALLY IF THE VIAL IS INVERTED. IF THE VIAL HAS BEEN INOCULATED, TREAT THE LEAK OR SPILL WITH CAUTION, AS PATHOGENIC ORGANISMS/AGENTS MAY BE PRESENT. BEFORE DISCARDING, STERILIZE ALL INOCULATED VIALS BY AUTOCLAVING. PRIOR TO EACH LOT¿S MANUFACTURING PROCESS, THE CAPPER SEALING AND SPINNING SECTIONS ARE EVALUATED, AND TECHNICIANS PERFORM CAP SEAL VERIFICATIONS DURING EVERY RUN. 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

    THERE WERE MULTIPLE 510K NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR THE ADDITIONAL 510K IS AS FOLLOWS: G4. PMA / 510(K)#: K222591. 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 AEROBIC/F CULTURE VIALS (PLASTIC) BLOOD LEAKED FROM ONE BOTTLE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) BLOOD LEAKED FROM ONE BOTTLE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1950963 BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) SYSTEM, BLOOD CULTURING MDB BECTON DICKINSON CARIBE LTD. 5093585 00382904420239

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown