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

Lot Number HM21009

Device Problem Contamination (1120)

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

Event Date 08/10/2022

Event Type  malfunction  

Event Description

When preparing an order for flolan in an aerogen 60ml syringe (lot: hm21009, exp: 02/28/2026), pharmacy tech noticed what appears to be a bit of a bug wing stuck to the inside of the syringe.After reconstituting the actual drug and pushing the drug/diluent into the aerogen syringe from a bd syringe, tech noticed something hanging down from the neck of the aerogen syringe.They used the needle attached to the bd syringe to push it up and out of the aerogen syringe, where they could grab it.It was attached well enough by some [invalid]like substance/material that they could feel it strain when they pulled it before it came loose.Products and substance was able to pass it back out for inspection by a pharmacist.Fda safety report id# (b)(4).

• Brand Name: AEROGEN 60 ML INHALATION SYRINGE
• Type of Device: NEBULIZER (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): AEROGEN LTD.
• MDR Report Key: 15216829
• MDR Text Key: 297965407
• Report Number: MW5111440
• 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: 08/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: HM21009
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Treatment: BD SYRINGE