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

Model Number BC 2029-W

Device Problems Hole In Material (1293); Leak/Splash (1354)

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

Event Date 06/05/2018

Event Type  malfunction  

Event 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
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CODAN US CORPORATION; 3511 west sunflower ave.; santa ana CA 92704
• MDR Report Key: 7609600
• MDR Text Key: 111343351
• Report Number: 7609600
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10813153021832
• UDI-Public: (01)10813153021832
• 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: 06/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: BC 2029-W
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/05/2018
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 06/05/2018
• 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