BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOJECT 3 ML SYRINGE WITH STANDARD HYPODERMIC NEEDLE 23GX1"

    MDR report key: 18183149 · Received November 20, 2023

    Report

    Report Number
    MW5148347
    Event Type
    Malfunction
    Date Received
    November 20, 2023
    Date of Event
    November 16, 2023
    Report Date
    November 17, 2023
    Manufacturer
    COVIDIEN/CARDINAL HEALTH 200, LLC.
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    LOCATION: (B)(6) HOSPITAL. ON 11/16/2023, RN REPORTED THE FOLLOWING: HIS INTENTION WAS TO ADMINISTER GENTAMICIN FOR HIS PATIENT. AFTER REMOVING GENTAMYCIN VIAL FROM THE OMNICELL DISPENSING CABINET, HE UNWRAPPED THE SYRINGE AND INTRODUCE SYRINGE INTO THE VIAL TO EXTRACT MEDICATION NEEDED. INITIALLY, THE VIAL CONTAINS CLEAR LIQUID SOLUTION BUT AS SOON SYRINGE/NEEDLE PUNCTURED THE VIAL, THE LIQUID TURNED BLUE. VIAL WAS SENT TO PHARMACY FOR INVESTIGATION. BOTH THE VIAL AND SYRINGE WERE INTACT PRIOR TO USAGE AND WERE NOT EXPIRED. PRODUCT INFORMATION: GENTAMICIN 80 MG/2 ML (40 MG/ML) NDC 63323-010-01, LOT# 6131256, EXPIRE DATE: 02/2025, MFD: FRESENIUS KABI, SYRINGE: MONOJECT 3 ML SYRINGE WITH STANDARD HYPODERMIC NEEDLE 23GX1" 2012 COVIDIEN, MADE IN USA COVIDIEN LLC, 15 HAMPSHIRE STREET MANSFIELD, MA 02048 USA, LOT # 238196.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1264915 MONOJECT 3 ML SYRINGE WITH STANDARD HYPODERMIC NEEDLE 23GX1" SYRINGE, PISTON FMF COVIDIEN/CARDINAL HEALTH 200, LLC. 238196

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other