BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRYPTIC SOY BROTH, USP, SERUM VIAL WITH NEEDLE PORT SEPTUM 20 ML MILLILITRE(S)

    MDR report key: 19885298 · Received July 31, 2024

    Report

    Report Number
    MW5157891
    Event Type
    Malfunction
    Date Received
    July 31, 2024
    Date of Event
    July 23, 2024
    Report Date
    July 24, 2024
    Manufacturer
    HARDY DIAGNOSTICS
    Product Code
    JSC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PARTICLE WAS FOUND IN EMPLOYEE MEDIA FILL VIAL. PARTICLE WAS "SALT-LIKE". WE HAVE BEEN SEEING VARIOUS PARTICLES/FLOATIES IN EMPLOYEE MEDIA FILLS. WE HAVE SENT SAMPLES TO THE EMPTY BAG BACK TO MANUFACTURE FOR INVESTIGATION OF PARTICULATES FOUND. COMMON ITEM USED IN BOTH VIAL AND BAG MEDIA FILLS IS THE TRYPTIC SOY BROTH USED. TSB VIALS MANUFACTURE: HARDY LOT # 622289, EXP: 10-30-2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1241713 TRYPTIC SOY BROTH, USP, SERUM VIAL WITH NEEDLE PORT SEPTUM 20 ML MILLILITRE(S) CULTURE MEDIA, GENERAL NUTRIENT BROTH JSC HARDY DIAGNOSTICS U38 622289

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown