BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AEROGEN CAP FOR 60ML SYRINGE NEBULIZATION

    MDR report key: 8196181 · Received December 24, 2018

    Report

    Report Number
    MW5082559
    Event Type
    Malfunction
    Date Received
    December 24, 2018
    Date of Event
    December 21, 2018
    Report Date
    December 21, 2018
    Manufacturer
    AEROGEN LTD.
    Product Code
    CAF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    A SEALED SYRINGE CAP PACKAGE WAS FOUND TO BE CONTAMINATED WITH AN ANT. IS THE PRODUCT OVER-THE- COUNTER? YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1032670 AEROGEN CAP FOR 60ML SYRINGE NEBULIZATION NEBULIZER (DIRECT PATIENT INTERFACE) CAF AEROGEN LTD. 174891

    Patients

    Seq Age Sex Outcome Treatment
    1