• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

AEROGEN AEROGEN SOLO CONTINUOUS NEBULIZATION SYRINGE; NEBULIZER Back to Search Results
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).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
AEROGEN SOLO CONTINUOUS NEBULIZATION SYRINGE
Type of Device
NEBULIZER
Manufacturer (Section D)
AEROGEN
EI 
MDR Report Key6879319
MDR Text Key87053060
Report NumberMW5072227
Device Sequence Number1
Product Code CAF
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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 Number06-AG-AS3085
Device Lot NumberHM16039
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received09/19/2017
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
-
-