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

Lot Number HM21009

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

Event Type  malfunction  

Event Description

Aerogen 60ml syringes are utilized for continuous nebulization of epoprostenol.We have reports from our pharmacy and rt colleagues that these syringes are leaking.It has been noted that the seal around the plunger is compromised and there is the presence of fluid passing the membrane.In addition, our pharmacy technicians have reported "weakened" plungers when filling the syringes.The manufacturer has been contacted and requested the impacted product to be returned.Impacted lot #s identified: hm20110 and hm21009.Reference report: mw5152946.

• Brand Name: AEROGEN 60ML CONTINUOUS NEBULIZER SYRINGE
• Type of Device: NEBULIZER (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): AEROGEN LTD.
• MDR Report Key: 18929077
• MDR Text Key: 338155399
• Report Number: MW5152947
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 03/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: HM21009
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1