MAUDE Adverse Event Report: CODAN US CORPORATION WALRUS; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	BC 2029-W
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/05/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Patient was in the bathroom when she noticed blood dripping from her iv tubing and nurse went into the bathroom and noticed blood backing up in iv tubing and dripping on the floor through a hole in the iv extension tubing.

• Brand Name: WALRUS
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CODAN US CORPORATION; 3511 west sunflower ave.; santa ana CA 92704
• MDR Report Key: 7609600
• Report Number: 7609600
• Device Sequence Number: 134558
• Product Code: FPA
• UDI-Device Identifier: 10813153021832
• UDI-Public: (01)10813153021832
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/05/2018
• Report Date (Section F): 06/05/2018

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: BC 2029-W
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 06/05/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 06/05/2018