MAUDE Adverse Event Report: AEROGEN LTD. AEROGEN SOLO; NEBULIZER (DIRECT PATIENT INTERFACE)

Lot Number MH19166

Device Problems Break (1069); Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Date 01/27/2021

Event Type  malfunction  

Event Description

Inhaled epoprostenol hub breaking off when rt goes to remove cap.This may be a manufacturing defect of the aerogen syringe.Rt was able to utilize the syringe due at 1730.

• Brand Name: AEROGEN SOLO
• 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: 11398701
• MDR Text Key: 234271214
• Report Number: 11398701
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/04/2021

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 Operator: Lay User/Patient
• Device Lot Number: MH19166
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/04/2021
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 03/02/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 22265 DA
• Patient Weight: 80