MAUDE Adverse Event Report: CARDINAL HEALTH; CATHETER, IRRIGATION

Model Number ASU1201

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 12/12/2017

Event Type  malfunction  

Event Description

Prior to utilizing on patient, the trumpet valve device was tested by the attending surgeon.The red button did not properly function.

• Type of Device: CATHETER, IRRIGATION
• Manufacturer (Section D): CARDINAL HEALTH; 785 fort mill hwy.; fort mill SC 29707
• MDR Report Key: 7137504
• MDR Text Key: 95469769
• Report Number: 7137504
• Device Sequence Number: 1
• Product Code: FEH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/12/2017,12/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: ASU1201
• Device Catalogue Number: ASU1201
• Device Lot Number: 041730
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/12/2017
• Event Location: Hospital
• Date Report to Manufacturer: 12/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1