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

Model Number	BC 564
Health Effect - Clinical Code	Pain (1994)
Date of Event	02/21/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It has been reported by our anesthesiologists that the codan minibore extention set with male luerlock are difficult to connect to the female luerlock on the perifix continious epidural.This is causing medication to leak from this connection leading to unnecessary labor pain.This patient's pain was able to be controlled after this connection was reinforced by anesthesia.This poor connection must be reinforced frequently to assure that patient's epidurals do not leak.

• Brand Name: CODAN
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CODAN US CORPORATION; 3511 west sunflower ave.; santa ana CA 92704
• MDR Report Key: 8394073
• Report Number: 8394073
• Device Sequence Number: 1436518
• Product Code: FPA
• UDI-Device Identifier: 00813153020005
• UDI-Public: (01)00813153020005
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/22/2019
• Report Date (Section F): 02/22/2019

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 564
• Device Catalogue Number: 71.7034
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/06/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/06/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Date Report Sent to FDA: 02/22/2019