BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AEROGEN 60 ML INHALATION SYRINGE

    MDR report key: 15216829 · Received August 11, 2022

    Report

    Report Number
    MW5111440
    Event Type
    Malfunction
    Date Received
    August 11, 2022
    Date of Event
    August 10, 2022
    Report Date
    August 10, 2022
    Manufacturer
    AEROGEN LTD.
    Product Code
    CAF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    WHEN PREPARING AN ORDER FOR FLOLAN IN AN AEROGEN 60ML SYRINGE (LOT: HM21009, EXP: 02/28/2026), PHARMACY TECH NOTICED WHAT APPEARS TO BE A BIT OF A BUG WING STUCK TO THE INSIDE OF THE SYRINGE. AFTER RECONSTITUTING THE ACTUAL DRUG AND PUSHING THE DRUG/DILUENT INTO THE AEROGEN SYRINGE FROM A BD SYRINGE, TECH NOTICED SOMETHING HANGING DOWN FROM THE NECK OF THE AEROGEN SYRINGE. THEY USED THE NEEDLE ATTACHED TO THE BD SYRINGE TO PUSH IT UP AND OUT OF THE AEROGEN SYRINGE, WHERE THEY COULD GRAB IT. IT WAS ATTACHED WELL ENOUGH BY SOME [INVALID]LIKE SUBSTANCE/MATERIAL THAT THEY COULD FEEL IT STRAIN WHEN THEY PULLED IT BEFORE IT CAME LOOSE. PRODUCTS AND SUBSTANCE WAS ABLE TO PASS IT BACK OUT FOR INSPECTION BY A PHARMACIST. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    326482 AEROGEN 60 ML INHALATION SYRINGE NEBULIZER (DIRECT PATIENT INTERFACE) CAF AEROGEN LTD. HM21009

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown BD SYRINGE