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

Model Number BC2029-W

Device Problems Break (1069); Difficult to Remove (1528)

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

Event Date 02/13/2017

Event Type  malfunction  

Event Description

Multiple stop cocks were connected to patient upon arrival to operating room.The rn attempted to remove one of the stop cocks and the stop cock snapped.There has been an issue with these stop cocks on multiple occasions.

• Brand Name: WALRUS
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CODAN US CORP.; 3511 west sunflower ave.; santa ana CA 92704
• MDR Report Key: 6485085
• MDR Text Key: 72543005
• Report Number: 6485085
• Device Sequence Number: 1
• Product Code: FPA
• 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: 03/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2017
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: BC2029-W
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/28/2017
• Event Location: Hospital
• Date Report to Manufacturer: 03/28/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 73 YR