MAUDE Adverse Event Report: HALYARD HEALTH, INC. HALYARD; GENERAL SURGERY TRAY (KIT)

Model Number 92794

Device Problem Hole In Material (1293)

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

Event Date 02/26/2018

Event Type  malfunction  

Event Description

There was a hole in the wall suction set that prevented the fluid from being suctioned.Due to this, another kit had to be opened to complete the procedure.

• Brand Name: HALYARD
• Type of Device: GENERAL SURGERY TRAY (KIT)
• Manufacturer (Section D): HALYARD HEALTH, INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 7482673
• MDR Text Key: 107220270
• Report Number: 7482673
• Device Sequence Number: 1
• Product Code: LRO
• UDI-Device Identifier: 10680651927948
• UDI-Public: (01)10680651927948
• 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: 04/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 11/30/2018
• Device Model Number: 92794
• Device Catalogue Number: 61450
• Device Lot Number: 0202857718
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/30/2018
• Event Location: Hospital
• Date Report to Manufacturer: 04/30/2018
• 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