MAUDE Adverse Event Report: AEROGEN LTD. AEROGEN® SOLO CONTINUOUS NEBULIZATION TUBE SET; NEBULIZER (DIRECT PATIENT INTERFACE)

Model Number	AG-AS3085
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Pharmacy staff reporting that they have recently noticed leaking from the back of aerogen syringes used to prepare veletri for inhalation.Leaking syringes were not dispensed and these products were re-made before sending for patient use.

• Brand Name: AEROGEN® SOLO CONTINUOUS NEBULIZATION TUBE SET
• Common Device Name: NEBULIZER (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): AEROGEN LTD.; 2500 bee cave road; bldg 1, suite 300; austin TX 78746
• MDR Report Key: 17001674
• Report Number: 17001674
• Device Sequence Number: 6343480
• Product Code: CAF
• UDI-Device Identifier: 05391517930405
• UDI-Public: (01)05391517930405
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 04/20/2023
• Report Date (Section F): 04/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: AG-AS3085
• Device Lot Number: HM21009
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 05/25/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/25/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 04/20/2023