BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRYPTICASE SOY BROTH

    MDR report key: 21513983 · Received March 4, 2025

    Report

    Report Number
    MW5167173
    Event Type
    Malfunction
    Date Received
    March 4, 2025
    Date of Event
    February 10, 2025
    Report Date
    February 27, 2025
    Manufacturer
    REMEL, INC.
    Product Code
    JSG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THIS AFFECTED MULTIPLE PATIENTS (86) WHO HAD TISSUE SPECIMEN CULTURES. ONE OF THE MICRO COLLEAGUES REPORTED SEEING A TREND WITH GRAM STAIN RESULTS OF STREPLIKE GRAM-POSITIVE COCCI IN CHAINS IN MULTIPLE SPECIMENS. NONE OF THE CULTURES WERE GROWING ANY ORGANISMS. AFTER AN EXTENSIVE INVESTIGATION, IT WAS DETERMINED THAT THE TRYPTICASE SOY BROTH THAT WE WERE USING TO GRIND THE TISSUE IN WAS CONTAMINATED. TEN BOTTLES OF THE BROTH WAS GRAM STAINED AND STREPLIKE GRAM-POSITIVE COCCI WERE FOUND IN THE TSB(TRYPTICASE SOY BROTH) BROTH. REFERENCE REPORTS: MW5167166, MW5167167, MW5167168, MW5167169, MW5167170, MW5167171, MW5167172, MW5167174, MW5167175.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2631554 TRYPTICASE SOY BROTH CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL JSG REMEL, INC. 185090

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male