BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3 ML SYRINGE

    MDR report key: 23276063 · Received October 14, 2025

    Report

    Report Number
    MW5177179
    Event Type
    Malfunction
    Date Received
    October 14, 2025
    Date of Event
    September 12, 2025
    Report Date
    October 7, 2025
    Manufacturer
    UNK
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    I WAS WORKING IN THE IV LAB IN THE IN-PATIENT PHARMACY ON (B)(6) 2025 WHEN I CAME ACROSS A PRODUCT THAT WE USE, TYPICALLY FOR NICU PATIENTS, HAD SIGNS OF PARTICULATE MATTER THAT WENT FROM THE BAG INTO THE SYRINGE THAT WAS DRAWN UP FOR A PATIENT. THE DRUG WAS GENTAMICIN, LOT: P461634, EXP: 11/30/26, AND THE SYRINGE THAT WAS USED WAS A 3ML SYRINGE WITH THE LOT: 5133250, EXP: 05/31/2030. I SPIKED THE BAG WITH A NON-VENTED DISPENSING PIN WITH THE INTENTION TO DRAW A FEW DOSES OUT OF THIS BAG FOR MULTIPLE PATIENTS BUT LUCKILY, I NOTICED THIS ODD PARTICULATE IMMEDIATELY IN THE FIRST SYRINGE. THE LOT OF THE DISPENSING PIN IS LOT: 00VL991908, EXP: 03/31/2030. THE SYRINGE CONTAINING THE PARTICULATE NEVER LEFT THE IV LAB AND I DISCARDED THE GENTAMICIN BAG AND SYRINGE INTO A BAG FOR MY COORDINATOR TO SEE. PATIENT CODE: 4582. DEVICE CODE: 1451, 2901, 2975. REFERENCE REPORT: MW5177180.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184462 3 ML SYRINGE NEEDLE, HYPODERMIC, SINGLE LUMEN FMI UNK 5133250

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown GENTAMICIN