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

Model Number AG-AS3085

Device Problem Material Disintegration (1177)

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

Event Date 06/20/2019

Event Type  Injury  

Event Description

Black rubber tip of aerogen syringe plunger started to dissolve during nebulization of epoprostenol in ns for pt.This resulted in a dark grey solution (clear drug in diluent mixed with fine, dark matter from rubber plunger tip.) as soon as nurse noticed, medication was switched for a new syringe and pharmacy and respiratory services were notified.Fda safety report id# (b)(4).

• Brand Name: AEROGEN 60 ML SYRINGE
• Type of Device: NEBULIZER (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): AEROGEN LTD; galway business park; galway ; EI
• MDR Report Key: 8735305
• MDR Text Key: 149479267
• Report Number: MW5087619
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): Y
• 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: 06/21/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2023
• Device Model Number: AG-AS3085
• Device Lot Number: 92211903060042
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR
• Patient Weight: 90