BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL¿ ENRICHED THIOGLYCOLLATE MEDIUM

    MDR report key: 25277072 · Received May 26, 2026

    Report

    Report Number
    1119779-2026-00858
    Event Type
    Malfunction
    Date Received
    May 26, 2026
    Date of Event
    April 16, 2026
    Report Date
    May 12, 2026
    Manufacturer
    BECTON DICKINSON & CO. (SPARKS)
    Product Code
    JSG
    UDI-DI
    30382902217870
    PMA / PMN Number
    K803023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER COULD NOT VERIFY WHICH BATCHES WERE USED IN PATIENT TESTING. THEY PROVIDED FOUR POSSIBLE BATCHES USED FOR PATIENT TESTING; D4. MEDICAL DEVICE EXPIRATION DATE: 2026-12-24 H4. DEVICE MANUFACTURE DATE: 2025-12-22 D4. MEDICAL DEVICE LOT#: 5356806 D4. UNIQUE IDENTIFIER (UDI) # (B)(4). D4. MEDICAL DEVICE EXPIRATION DATE: 2026-10-22 H4. DEVICE MANUFACTURE DATE: 2025-10-22 D4. MEDICAL DEVICE LOT#: 5295069 D4. UNIQUE IDENTIFIER (UDI) # (B)(4). D4. MEDICAL DEVICE EXPIRATION DATE: 2026-08-27 H4. DEVICE MANUFACTURE DATE: 2025-08-28 D4. MEDICAL DEVICE LOT#: 5240858 D4. UNIQUE IDENTIFIER (UDI) # (B)(4). D4. MEDICAL DEVICE EXPIRATION DATE: 2026-12-03 H4. DEVICE MANUFACTURE DATE: 2025-12-03 D4. MEDICAL DEVICE LOT#: 5337816 D4. UNIQUE IDENTIFIER (UDI) # (B)(4). 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

    IT WAS REPORTED WHILE USING BD BBL¿ ENRICHED THIOGLYCOLLATE MEDIUM TUBES, THE MEDIA WAS CLOUDY FOLLOWING THE HEATING STEPS. AFTER FOLLOWING UP FOR MORE INFORMATION, WE ARE UNABLE TO CONFIRM THE NUMBER OF TUBES AND BATCH NUMBERS USED FOR PATIENT TESTING. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244827 BD BBL¿ ENRICHED THIOGLYCOLLATE MEDIUM CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL JSG BECTON DICKINSON & CO. (SPARKS) UNKNOWN 30382902217870

    Patients

    Seq Age Sex Outcome Treatment
    1