MAUDE Adverse Event Report: CARDINAL HEALTH HYDROLINE TRUMPET VALVE

Model Number ASU1201

Device Problems Device Operates Differently Than Expected (2913); No Pressure (2994)

Patient Problem No Information (3190)

Event Date 12/28/2017

Event Type  malfunction  

Event Description

While pt in operating room, the hydroline trumpet valve irrigation tubing would not function during surgical procedure.The irrigation did not have pressure behind it.

• Brand Name: HYDROLINE TRUMPET VALVE
• Type of Device: HYDROLINE TRUMPET VALVE
• Manufacturer (Section D): CARDINAL HEALTH; dublin OH 43017
• MDR Report Key: 7159811
• MDR Text Key: 96344609
• Report Number: MW5074363
• Device Sequence Number: 1
• Product Code: GBX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/30/2018
• Device Model Number: ASU1201
• Device Catalogue Number: ASU1201
• Device Lot Number: 071740
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 79 YR