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

Model Number AG-AS3085

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/18/2023

Event Type  malfunction  

Event 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
• Type of Device: NEBULIZER (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): AEROGEN LTD.; 2500 bee cave road; bldg 1, suite 300; austin TX 78746
• MDR Report Key: 17001674
• MDR Text Key: 315925196
• Report Number: 17001674
• Device Sequence Number: 1
• Product Code: CAF
• UDI-Device Identifier: 05391517930405
• UDI-Public: (01)05391517930405
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2023
• 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
• Date Report Sent to FDA: 04/20/2023
• Event Location: Hospital
• Date Report to Manufacturer: 05/25/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1