MAUDE Adverse Event Report: AEROGEN AEROGEN SOLO CONTINUOUS NEBULIZATION SYRINGE; NEBULIZER

Catalog Number 06-AG-AS3085

Device Problems Manufacturing, Packaging or Shipping Problem (2975); Material Integrity Problem (2978)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  No Answer Provided  

Event Description

Aerogen has discontinued a solo luer adaptor that allowed for use of bd syringes to deliver respiratory medications through a syringe pump.Aerogen is now manufacturing its own syringe, as part of a continuous nebulization tube set, for delivery of respiratory medications.The syringe is labeled as non-sterile.This is a problem at usp 797 designates compounded medications for inhalation as being sterile products.With aerogen's syringe we are not able to provide a sterile product for inhalation (such as epoprostenol).

• Brand Name: AEROGEN SOLO CONTINUOUS NEBULIZATION SYRINGE
• Type of Device: NEBULIZER
• Manufacturer (Section D): AEROGEN; EI
• MDR Report Key: 6879319
• MDR Text Key: 87053060
• Report Number: MW5072227
• 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: 09/18/2017

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 06-AG-AS3085
• Device Lot Number: HM16039
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/19/2017
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1