MAUDE Adverse Event Report: AEROGEN INC AERONEB CLAMP BRACKET

Catalog Number 06-AG-AP-1060

Device Problems Component Falling (1105); Crack (1135); Inaccurate Delivery (2339)

Patient Problem Underdose (2542)

Event Date 04/22/2015

Event Type  malfunction  

Event Description

The plastic u-clamp that allows the aerogen to attach to a pole developed a crack when tightened (unknowingly).The clamp gave out causing the aerogen to fall, pulling the cannula out of the patient's nose and causing medication to no longer be delivered as intended.(this has happened on multiple occasions.).

• Brand Name: AERONEB CLAMP BRACKET
• Type of Device: CLAMP
• Manufacturer (Section D): AEROGEN INC; 816 congress avenue; suite 1400 TX 78701
• MDR Report Key: 4790452
• MDR Text Key: 5804496
• Report Number: 4790452
• Device Sequence Number: 1
• Product Code: CAF
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 05/06/2015

1 Device was Involved in the Event

2 Patient was Involved in the Event

• Date FDA Received: 05/06/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Invalid Data
• Device Catalogue Number: 06-AG-AP-1060
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 1 YR
• Event Location: Hospital
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1