BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AEROGEN SOLO SYRINGE

    MDR report key: 17435653 · Received July 31, 2023

    Report

    Report Number
    MW5120408
    Event Type
    Malfunction
    Date Received
    July 31, 2023
    Date of Event
    July 27, 2023
    Report Date
    July 27, 2023
    Manufacturer
    AEROGEN LTD
    Product Code
    CAF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    AEROGEN SYRINGES SEEM TO BE DEFECTIVE. THEY COME WITH THE MEDICATION PRE-FILLED FOR USE IN ALARIS PUMP WITH AEROGEN SETUP FOR CONTINUOUS NEBULIZATION USE WITH THE VENT. WHEN I TOOK THE CAP OFF THE SYRINGE, HOOKED IT TO THE TUBING, AND TURNED IT UPSIDE DOWN TO HOOK IT UP THROUGH THE ALARIS, THE MEDICATION SOLUTION WAS FREE FLOWING OUT THE BOTTOM AND OVERFILLED THE NEBULIZER CUP. MEDICATION SPILLED ON THE EQUIPMENT AND ON THE FLOOR. WHEN I TOOK THE SYRINGE OUT TO TROUBLESHOOT, MEDICATION WAS STILL DRIPPING FREELY OUT OF THE BOTTOM OF THE SYRINGE. UPON INSPECTION, THE SYRINGE PLUNGER WAS NOT HOLDING. THIS HAPPENED WITH ANOTHER DOSE FROM THE SAME BATCH THAT WAS DELIVERED, AND THEN A DOSE FROM THE NEXT BATCH FROM PHARMACY AS WELL. REFERENCE REPORTS: MW5120407, MW5120409.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1469961 AEROGEN SOLO SYRINGE NEBULIZER (DIRECT PATIENT INTERFACE) CAF AEROGEN LTD 21I230029

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown