MAUDE Adverse Event Report: AEROGEN LTD. AEROGEN CAP FOR 60ML SYRINGE NEBULIZATION; NEBULIZER (DIRECT PATIENT INTERFACE)

Lot Number 174891

Device Problem Contamination of Device Ingredient or Reagent (2901)

Patient Problem No Information (3190)

Event Date 12/21/2018

Event Type  malfunction  

Event Description

A sealed syringe cap package was found to be contaminated with an ant.Is the product over-the- counter? yes.

• Brand Name: AEROGEN CAP FOR 60ML SYRINGE NEBULIZATION
• Type of Device: NEBULIZER (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): AEROGEN LTD.
• MDR Report Key: 8196181
• MDR Text Key: 131765183
• Report Number: MW5082559
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 12/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/24/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 174891
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1