BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL¿ MIDDLEBROOK OADC ENRICHMENT

    MDR report key: 22935054 · Received September 2, 2025

    Report

    Report Number
    1119779-2025-04755
    Event Type
    Malfunction
    Date Received
    September 2, 2025
    Date of Event
    August 5, 2024
    Report Date
    July 10, 2025
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    PPM
    UDI-DI
    00382902123514
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E.1. INITIAL REPORTER ADDR 1: (B)(6). INVESTIGATION SUMMARY: MATERIAL 212351 IS MANUFACTURED BY REHYDRATING THE MEDIA COMPONENTS WITH USP PURIFIED WATER, THOROUGHLY MIXING UNTIL A HOMOGENEOUS SOLUTION IS OBTAINED, AND THE SOLUTION IS THEN STERILE FILTERED. BOTTLES ARE FILLED AND CAPS ARE APPLIED AND TORQUED MECHANICALLY PER STANDARD OPERATING PROCEDURE (SOP). BOTTLES ARE THEN SENT TO A SEPARATE PACKAGING AREA FOR LABELING AND TO BE PACKED INTO FINAL SHIPPING CONFIGURATIONS. THE BATCH HISTORY RECORD REVIEW WAS SATISFACTORY PER INTERNAL PROCEDURES. QC INSPECTION AND TESTING WAS SATISFACTORY AT TIME OF RELEASE. THE RELEASE TESTING THAT IS PERFORMED ON THIS PRODUCT DOES INCLUDE MEDIA APPEARANCE. NO FOREIGN OBJECTS WERE OBSERVED IN QC SAMPLES AT THE TIME OF RELEASE. IF FOREIGN MATTER HAD BEEN NOTED DURING QC TESTING, THE PRODUCT IT WOULD HAVE BEEN PLACED ON QUALITY NOTIFICATION AND FURTHER ANALYSIS INCLUDING 100% INSPECTION OF THE BATCH WOULD HAVE BEEN CONDUCTED. THE COMPLAINT HISTORY WAS REVIEWED, AND NO OTHER COMPLAINTS HAVE BEEN TAKEN ON BATCH 3277890. AT THE TIME OF THE INVESTIGATION, THE BATCH WAS EXPIRED, AND RETENTION SAMPLES WERE NOT AVAILABLE FOR INVESTIGATION. THREE PHOTOS WERE RECEIVED FOR INVESTIGATION OF THIS COMPLAINT. PHOTOS SHOW CLOUDY MEDIA IN BOTTLES FROM BATCH 3277890. THIS COMPLAINT CAN BE CONFIRMED FROM THE PHOTOS PROVIDED. NO COMPLAINT TREND HAS BEEN IDENTIFIED; NO ACTIONS ARE INDICATED AT THIS TIME. BD WILL CONTINUE TO TREND COMPLAINTS. THIS MDR IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW OF RECORDS DATING APRIL 2023-2025, UNDER CAPA 11910483.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD BBL¿ MIDDLEBROOK OADC ENRICHMENT, THE MEDIA WAS CONTAMINATED. THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248123 BD BBL¿ MIDDLEBROOK OADC ENRICHMENT GENERAL PURPOSE REAGENT PPM BECTON, DICKINSON & CO. (SPARKS) 3277890 00382902123514

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown