MAUDE Adverse Event Report: HALYARD HEALTH, INC. HALYARD; PUMP, INFUSION, ELASTOMERIC

Model Number	13476
Health Effect - Clinical Code	No Information (3190)
Date of Event	09/28/2017
Type of Reportable Event	Malfunction
Event or Problem Description
Patient q-ball medication found to be empty.It was later noted that the catheter was brittle and broken in two.

• Brand Name: HALYARD
• Common Device Name: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): HALYARD HEALTH, INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 6972030
• Report Number: 6972030
• Device Sequence Number: 16450824
• Product Code: MEB
• UDI-Device Identifier: 10680651134766
• UDI-Public: (01)10680651134766
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 10/12/2017
• Report Date (Section F): 10/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: 13476
• Device Catalogue Number: CB6004
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 10/09/2017
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/24/2017
• Patient Sequence Number: 1
• Date Report Sent to FDA: 10/09/2017